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CANADIAN VIGOUR CENTRE

Bridging hearts and minds to enhance cardiovascular care

Inside this issue: Letter 1 PW Armstrong Trial Updates

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Monitoring

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Biostatistics

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CVC Publications and Abstracts

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Volume 17, No. 3

Winter 2013

Letter from Dr. Paul Armstrong: A foot of fresh snow blankets the ground and the days grow shorter as the winter solstice approaches in northern Alberta. Now that Canadian - and more recently American - Thanksgiving holidays are in the rear view mirror and Christmas approaches, it is a fine time to reflect on our many blessings. The origins of Canadian Thanksgiving, celebrated on the second Monday of October, can be traced to the freezing and stormy sail of Martin Frobisher who, after finally anchoring in Frobisher Bay off Baffin Island, was prompted by his accompanying minister to be “thankful to God for their strange and miraculous deliverance in those so dangerous places”. By contrast the first Thanksgiving in the United States, celebrated on the third Thursday of November, is generally attributed to the pilgrim feast in Plymouth Massachusetts in 1621 after the first harvest that followed a particularly difficult winter. Canada and the United States share many things. When John Kennedy addressed the Canadian parliament a few months after he was elected President of the United States in 1961, he reflected that “Geography has made us neighbors, history has made us friends, economics has made us partners, necessity has made us allies. What unites us is far greater than that which divides us.” Sometimes amidst the challenges associated with achieving our academic mission and pushing the boundaries to acquire new and clinically relevant knowledge, it is tempting to become dispirited. It is at just those times that it is crucial to recall that our major limitations are few and largely related to the quality of our ideas, the resourcefulness and skill with which we develop and communicate them, and the passion and tenacity necessary to realize them. The spirit of collaboration shared across the longest unpatrolled border in the world separating Canada and the US is alive and well, as it is with many of our global partners around the world. The sharing of our ideas through clinical trials, registries and population health outcomes data inform us while at the same time generating a more lucid path forward. The recruitment of young people to the cause, supporting their training in other academic centres and countries, as well as the enrichment provided by academic visits to our different institutions is a most welcome signal of this collaborative spirit. In just the last 60 days, I have had splendid learning experiences and the great privilege of working with friends and colleagues in Montreal, Quebec, Sydney, Australia, the University of Leuven in Belgium, Dallas, Texas and Stanford University in California. Within this issue of the Chronicle, the collaborative spirit and opportunities are reflective of an abundant harvest and we are thankful to our many partners that enable this. That said, I wish to particularly highlight the outstanding work of Warren Cantor and his study coordinator Kim Robbins at the Southlake Medical Centre in Ontario and sincerely thank them for energizing our investigation of a novel anticoagulation system in the Regulate PCI Trial with great velocity. More details on the trial and their team are featured in this issue of the Chronicle. As we reflect on our many blessings at this hinge point in the calendar, it is good to recall that “to whom much is given, much will be required”. From our team at the Canadian VIGOUR Centre to yours, we genuinely extend our warmest wishes for a Merry Christmas, Happy Hanukkah and enjoyable holiday season. We hope it finds you amidst the warmth of family and friends, replenishing your energy and spirits and preparing to seize the novel opportunities afforded by the dawn of the new year ahead. With kind regards,

CVC is proud to be a University of Alberta Centre

Paul W. Armstrong

www.vigour.ualberta.ca


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IMPROVE-IT

IMProved Reduction of Outcomes: Vytorin Efficacy International Trial Sponsored by Merck & Co. Inc., (previously ScheringPlough Research Institute) this trial is a multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin (ezetimibe/ simvastatin Tablet) vs. simvastatin monotherapy in high-risk patients presenting with acute coronary syndrome. ClinicalTrials.gov Identifier: NCT00202878

As we approach 2014, the year that the IMPROVE IT trial expects to reach the protocol-defined number of clinical endpoints, the focus becomes data cleanliness, in addition to patient retention. On the patient retention front, the Participant Newsletter (Memo #407B) was sent to sites in early September. Please forward your REB approval letters to CVC. The data cleanliness effort began with Memo #408 (“New Expedited Queries to be issued”) in late August, and continues with the Data Cleaning Initiative which began in late October. We continue to work on answering outstanding AE QC queries. Remember, if an AE is not an endpoint, then the AE must clearly state this. Emails have been sent to those sites that either have queries that are still open, or queries that were answered incorrectly. Your cooperation in addressing these important “AE QC” data queries within 10 days is appreciated.

Data Clean Up – Commendations to ALL of the IMPROVE IT CVC sites on achieving >/= 97%!!! As of November 13 20 sites have achieved 100% monitor clean data, and another 11 sites have achieved 98-99% monitor clean data (this is a record for the year!!) As a reminder, an email was sent to all sites in September regarding the PR Status Reports for study drug. These two reports are to be printed and filed in your Investigator Site File (in the Drug Accountability Binder). The monitors will be verifying that these reports are on site and filed accordingly. CEC Adjudicated Events – please remember to submit any outstanding (de-identified) source documents to the TIMI CEC. For further information, please contact Clinical Trial Project Lead Jodi Parrotta at 1-800-707-9098 (ext. 3) or by email at jodi.parrotta@ualberta.ca.

Data Cleaning Initiative: a targeted data sweep has been issued from October 21 - December 13, 2013 with the goal to have all data from study visits entered into INFORM by the end of 2013. The data sweep will target all late visits, missing data, and opened/answered critical queries that are more than 10 days late. As always, we appreciate your assistance, and time, on these initiatives!

ODYSSEY OUTCOMES

Sponsored by Sanofiaventis Recherche & Développement this is a randomized, double-blind, placebo-controlled, parallel -group study to evaluate the effect of SAR236553/ REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an Acute Coronary Syndrome. ClinicalTrials.gov Identifier: NCT01663402

ODYSSEY Outcomes is one of 12 Phase III trials that have been initiated as part of the more than 23,000 patient ODYSSEY clinical trial program. The first Phase III study (ODYSSEY MONO) to report data from the ODYSSEY clinical trial program showed that it met its primary efficacy endpoint: the mean LDL-C reduction from baseline to week 24, was significantly greater in patients randomized to alirocumab, as compared to patients randomized to Ezetimibe (47.2% vs. 15.6%, p<0.0001). The ODYSSEY Outcomes trial is well underway with over 1400 patients randomized globally. In Canada, 28 sites have been activated with more than 80 patients screened and 20 randomized. We are looking forward to activating the remainder of our sites over the coming months with further increase in screening and recruitment efforts at all sites in Canada. Don’t forget to complete all your training and regulatory documents while you are waiting on contracts and ethics! For those sites that have

now screened and/or randomized a patient, don’t forget to complete your CRF’s and answer any open queries. Please keep an eye out for key trial updates and Canadian newsletters sent out to your site throughout the trial. The upcoming Protocol Amendment 2—pending FDA acceptance—is expected soon. We tentatively plan to submit to Health Canada before end of the year with approval in early 2014. We anticipate this will help to boost recruitment at participating sites in the coming months. More details will be forthcoming in the near future. We’ve had some recent changes to the ODYSSEY team at CVC and Robert Evans has now transitioned off of the project. We are still recruiting a few final sites for this study so if you are interested in hearing more about ODYSSEY or have questions regarding the trial, please contact Clinical Trial Project Lead Amanda Carapellucci at 1-800-707-9098 (ext. 2) or by email at amanda.carapellucci@ualberta.ca or Paula Priest (ext. 9) or paula.priest@ualberta.ca.


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Volume 17, No. 3

STABILITY In mid November, GSK released the top-line results from this study which showed that the study did not meet its primary endpoint of time to first occurrence of any major adverse cardiovascular event (MACE). This is a rich set of data which will be closely analyzed in the coming months and we look forward to sharing the full results in 2014. We appreciate all the hard work from our 32 Canadian sites and all the patients who contributed to this study over the last five years. As we clean up and finalize the study files, please make sure to send a copy of your ethics

submission and acknowledgement of study closure letters as well and your FIDS B forms for end of study to us at the Canadian VIGOUR Centre. As you start to think about archiving your study files, please remember that all study related documents will need to be archived for 25 years per Health Canada regulations. If you have any questions or require additional information, please contact Assistant Director, Clinical Trials, Tracy Temple @ 1-800-707-9098 (ext. 5) or via email at tracy.temple@ualberta.ca.

REGULATE PCI The REGULATE-PCI held its first North American Investigator Meeting (IM) in October in Chicago. It was a great opportunity to meet face-to-face with many of our sites and learn about the protocol and overall study. If you were unable to attend that meeting, the next North American IM will be occurring in late February 2014 (location to be determined). The study is now underway across North America with over 90 patients enrolled at nine sites. In Canada, Dr. Cantor’s site continues to excel! To date, they have enrolled 30 patients, and remain the highest global enroller – a title they have held for nearly two months! Congratulations to Dr. Cantor and his team!! They are a shining example of what five engaged interventionalists and one keen study coordinator (Kim Robbins) can accomplish together (see picture inset)! In November, two more sites were activated in Canada: Dr. Fung in Vancouver, BC and Dr. Mehta in Hamilton, ON. We look forward to these two sites enrolling their first patients in the coming weeks.

We will be working hard to get the remainder of our sites activated in the next couple of months and look forward to having all of our sites recruiting early in the new year. For further information, or if you are interested in participating, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800-707-9098 (ext. 3) or by email at jodi.parrotta@ualberta.ca.

From L to R: Dr Cantor, Dr Miner, Kim, Dr Plante and Dr Prabhakar (missing Dr Goldman)

STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY Sponsored by Glaxo SmithKline, this trial is a randomized, placebocontrolled, double-blind, parallel group, multicenter, event-driven clinical outcomes study of darapladib versus placebo in subjects with chronic coronary heart disease to compare the incidence of major adverse cardiovascular events. ClinicalTrials.gov Identifier: NCT00799903

Sponsored by Regado Biosciences Inc. this is a randomized, open-label, multi-center, activecontrolled, parallel group study to determine the efficacy and safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention Clinical trials.gov Identifier: NCT01848106

PROACT PROACT The Edmonton Emergency Medical Services (EMS) teams continue to actively recruit patients, with over 180 patients now enrolled into the study. We appreciate their continued hard work and commitment to this study.

Keep up the great work! The 2011/2012 phase of the study was presented as a Late Breaking Trial at the Canadian Cardiovascular Congress in Montreal in October and there was also a Poster Presentation of the study methods and baseline characteristics “Providing Rapid Out Of Hospital Acute Cardiovascular Treatment: PROACT 3”. For further information please contact Paula Priest at 1-800-707-9098 (ext. 9) or email at paula.priest@ualberta.ca.

Providing Rapid Out of Hospital Acute Cardiovascular Treatment An Edmonton-region local initiative sponsored by the University Hospital Foundation and the Mazankowski Alberta Heart Institute. Additional support for point of care meters provided by Alere Inc. ClinicalTrials.gov Identifier: NCT01634425


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AEGIS-I Sponsored by CSL Behring LLC, this study is a Phase 2b, multicenter, randomized, placebocontrolled, dose-ranging study to investigate the safety and tolerability of multiple dose administration of CSL112 in subjects with acute myocardial infarction.

AEGIS-I is a new Phase 2 study investigating the safety and tolerability of multiple dose administration of CSL112 in subjects post acute myocardial infarction. CSL112 is an intravenous apo lipoprotein A-I (apoA-I), purified from human plasma and reconstituted to form HDL particles. It has shown promise in earlier phase 1 and 2 studies with its ability to rapidly remove cholesterol from atherosclerotic plaque.

For further information, or if you are interested in hearing more about this study, please contact Assistant Director, Clinical Trials, Tracy Temple at 1-800-707-9098 (ext. 5) or by email at tracy.temple@ualberta.ca.

We are pleased to be closely collaborating with the sponsor, CSL, in addition to the Duke Clinical Research Institute, the PERFUSE study group, the Cleveland Clinic and Quintiles on this study. The Canadian VIGOUR Centre will be responsible for Project/Site Management and Monitoring for all participating Canadian sites. Initial invitations have gone out to select Canadian sites who we look forward to working through feasibility and start up with over the next few months.

TECOS After a successful Rejuvenation Meeting in Boston this November, we are confident that our TECOS sites are feeling revitalized and ready to take on the final stages of this study! The focus of this meeting was to review the plans and expectations surrounding the anticipated study end date in the later part of 2014. The timelines for final patient visits and data lock once the number of adjudicated events has been met will be tight, so there is a push for sites to enter data not only quickly but meticulously over the next year, which will help decrease the number of queries generated by data management and the clinical events committee. Missing data and/or data queries are expected to be cleaned before reaching the 30 day old mark. Also, please ensure that Principal Investigators are signing SAE casebooks promptly after the initial data entry is complete. Sponsored by Merck & Co. Inc., TECOS is a Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control. ClinicalTrials.gov Identifier: NCT00790205

Congratulations to the following sites with outstanding data items < 30 days!

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Dr. Woo & Dixie Hak Dr. Kaiser & Laura Lee Magennis Dr. Dumas & Sylvie Gauthier Dr. Garceau & Lise Mercier Dr. Yale & Mylene Roy Dr. Mereu & Bonnie Woloschuk Dr. Pandey & Sandra Clarus Dr. Saunders & Lori Richert Dr. Huynh & Linda Perkins

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Dr. Weisnagel & Valerie-Eve Julien Dr. Sigalas & Darlene Hutton

For any patients that have permanently discontinued study drug or have withdrawn consent for participation in the study, it is crucial that sites are maintaining the appropriate logs and worksheets related to these events and are submitting them to CVC on a regular basis. The Project Team must enter detailed data for each of these patients into a special section of Inform and we cannot do this without your help! A friendly reminder to please review your contracts and submit all current invoices to CVC so that you are reimbursed in a timely manner and there is not a frantic rush to get these processed during study close-out. Lyndsey Garritty will be transitioning off the project in December as she prepares for an upcoming maternity leave. We are currently working on shifting TECOS to Robert Evans, who some of you may have worked with on the ODYSSEY Outcomes study. For further information or questions, please contact Clinical Trial Project Lead, Lyndsey Garritty at 1-800-707-9098 (ext. 4) or via email at lyndsey.garritty@ualberta.ca or Robert Evans (ext. 1) or robert.evans@ualberta.ca.


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Volume 17, No. 3

GUIDE-IT GUIDE-IT is well under way in Canada with our first two patients enrolled and 4 of our planned 6 sites activated and working hard at screening patients. In North America there are now over 150 patients enrolled with most sites now activated. Congratulations to Dr. Patricia Campbell, Kim Ronak & Sheilah Heal at the University of Calgary/ Foothills Hospital for enrolling the first two Canadian GUIDE-IT patients. Congratulations to our other active sites:

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Dr. Justin Ezekowitz & Quentin Kushnerik – University of Alberta Hospital/ Mazankowksi Alberta Heart Institute, Edmonton Dr. Robert McKelvie, Barb Miller & Lydia Morrow – Hamilton Health Sciences, Hamilton Dr. Mustafa Toma, Liz Grieve & Cynthia Van Hoof – St. Paul’s Hospital, Vancouver

As screening and enrollment activities heat up, please ensure that you are reviewing your patient recruitment plans and revising these as needed. CVC and DCRI will be requesting your updated plans on a regular basis. Screening logs should be sent to CVC every Thursday. These logs are very helpful and assist the Project Team in identifying enrollment challenges. Thank you to each of our sites for working hard on obtaining Protocol Amendment 1 approval so quickly. The inclusion/exclusion revisions in this amendment should provide for a wider range of

patient eligibility. For those enrolling sites please ensure that source documents are being sent in and Inform data entered within 5 business days of each visit. Please refer to the GUIDE-IT website for the most current versions of the eCRF Instructions, study documents, training items, etc. The website also houses a Frequently Asked Questions document that is updated continuously. Monthly GUIDE-IT teleconferences have now been scheduled for both PI’s and Study Coordinators to attend, which will provide an excellent venue to gather new screening ideas, understand some of the challenges to enrollment and possible solutions, and to also ask any questions you may have about the study. Please check your email or contact CVC for scheduled dates and times. Thank you to all of our GUIDE-IT sites for your commitment to participate in this important heart failure study. We are looking forward to working with each of you closely to make this trial a success!

SODIUM-HF is just getting started with an anticipated 15 sites across Canada expected to participate. Initial invitations have gone out with an overwhelming response to date! Regulatory documents are being reviewed at several sites and

ClinicalTrials.gov Identifier: NCT01685840

Lyndsey Garritty will be transitioning off the project throughout December as she prepares for an upcoming maternity leave. We are pleased to have Melisa Spaling, assuming the role of Project Lead on this study in the coming weeks. If you have not already connected with Melisa she will be in touch with all participating sites this month. For further information, please contact Melisa Spaling, Clinical Trial Project Lead at 780-492-8476 or via email at mspaling@ualberta.ca

SODIUM-HF Based on the success of the SODIUM-HF pilot, Phase III of the SODIUM-HF trial aims to evaluate the long-term effects of a low-sodium containing diet compared to Usual Care in over 1,000 patients with heart failure.

In collaboration with DCRI (Duke Clinical Research Institute) and Roche GUIDE-IT is a prospective, randomized 1:1, multicentre clinical trial GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure

we plan to activate our first site in early 2014. If you are a participating site, we look forward to working with you to make this trial a success. If you are interested in participating in SODIUMHF or would like further information, please contact Clinical Trial Project Lead Melisa Spaling at 780-492-8476 or via email at mspaing@ualberta.ca

SODIUM-HF Funded by the Canadian Institute of Health Research (CIHR), SODIUM-HF is a multicenter, randomized, open-label Study of Dietary Intervention Under 100 MMOL in Heart Failure.


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THE CANADIAN CARDIAC CHRONICLE

EXSCEL The EXSCEL trial is moving right along with over 8300 subjects enrolled globally. Our 24 Canadian sites have been able to contribute 330 subjects, and that number continues to steadily increase. With the planned expansion and increase in total enrollment for the EXSCEL trial, your continued support will be critical to the success of the trial!

Exenatide Study of Cardiovascular Event Lowering Sponsored by Amylin Pharmaceuticals, Inc. this trial is a pragmatic, long term, placebo-controlled, double-blinded trial which seeks to characterize the effects of exenatide once weekly on cardiovascular (CV) -related outcomes in patients with type 2 diabetes when added to the current usual care for glycemic control in a standard care setting. ClinicalTrials.gov Identifier: NCT01144338

As your excellent screening and enrollment work continues, we will begin to take a closer look at our retention metrics. So far our Canadian sites have done a fantastic job of retaining patients in the study and we hope to see that trend continue. Every patient is important – so please ensure you contact the EXSCEL study Hotline to discuss all cases of patients coming off study drug or potentially withdrawing consent. If you have any questions or concerns, we encourage you to contact your project lead to discuss them and to review all the alternative options that are available to your patients.

We would like to congratulate one of our most recently activated sites, Dr. R. Kuritzky and his staff at Fraser Clinical Trials, who quickly enrolled 13 patients in 4 months. Currently they hold the top spot for ratio of patients enrolled per month! Additionally we would like to acknowledge our other top enrolling sites for the months of August The Amendment 4 transition is currently 96% complete for Canada. This would not have been 2013 through to October 2013: possible without the continued cooperation of  Institut Universitaire de Cardiologie et de each of our sites – thank you to each of you! We Pneumologie de Québec, PI – Dr. F. Dubé, are excited for the upcoming changes from our SC – Marilène Bolduc new sponsor and we look forward to seeing many  Surrey Memorial Hospital – Cardiology of you at the EXSCEL North American Clinical Trials, PI – Dr. S. Cheung, SC – Tracy Rejuvenation Meeting, scheduled for January 2014! Cleveland For further information or if you are interested in  The Ottawa Hospital, PI – Dr. H. Lochnan, participating in this trial, please contact Clinical SC – Denise DeCurtis Trial Project Lead, Amanda Carapellucci at A big thank you to these sites and to all sites who 1-800-707-9098 (Ext 2) or by email at continue to actively screen and enroll patients amanda.carapellucci@ualberta.ca or Diane your efforts and enthusiasm for the EXSCEL trial Camara at 1-800-725-6585 or by email at are greatly appreciated! dcamara@chrc.net.

MONITORING In our last issue we highlighted several audit tips and thought we would continue them into this issue as we feel that sharing these will help us all to be better prepared for that next audit.

 Ensure you have, at minimum, Standard

process with each patient should be documented as per your SOP whether you use a consent process checklist or it is hand written in the progress note. Any consent amendments should be provided to the subject at the next clinic visit after receiving ethics approval.

Operating Procedures (SOPs) on the consent process, AE/SAE documentation and submission  Ensure all site staff are listed on the delegation log and that the responsibilities of each staff to sponsor/ethics, study drug storage, dispensing member are assigned by the principal and return, screening and eligibility of subjects, investigator (PI) who should sign, initial, and date source documentation, and record retention. each entry. While we all know how important And don’t forget that every staff member should study coordinators (SC) are in running a trial be trained on the site SOPs and the training remember they cannot be assigned the following documented. responsibilities: (1) eligibility of subjects and (2)  Consenting of subjects should be done per your assessment of AE/SAE’s. The SC can screen site SOP. The subject should print, sign and subjects and collect AE/SAE’s. If the delegation date the consent and initial each page (if log has codes and there are no separate codes applicable. The date of the consent should be in for SC to screen or collect information you can the format that has been approved by the REB. always use “other” or add additional codes For example if the REB wants the date to be listing what the responsibility is. Finally, any documented as DD/MM/YYYY, then the date deletion or additions to the log are to be signed/ should be written as 10/09/2013 to note that it initialed and dated by the PI not the SC or other is 10th day of September 2013. The study team site staff. member who administers the consent should For monitoring related questions please contact review that the consent is properly completed Lead CRA, Halina Nawrocki at 1-905-896-7292 including the format of the date. The consent or by email at halina.nawrocki@rogers.com.


Volume 17, No. 3

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2013 International Year of Statistics: How Statistics Impacts You While “celebrating” and “statistics” would not often be found together in a sentence in common conversation, we predict that there has been a significant increase in its frequency in 2013. This year marks the International Year of Statistics with its aim of increasing awareness of the impact of statistics across many facets of our lives. Those of us in clinical research, however, have recognized its invaluable contribution for some time. This art and science of learning from (or making sense out of) data may seem daunting to some, but for those of us who have made it our career, we take our role seriously. Being the bridge between the collected data and answering clinical questions is central to what we do. Involving those with such expertise, and doing so early on, goes a long way in terms of the credibility of clinical research. This has been a long-standing commitment at the CVC. Our biostatistics team is made up of applied methodologists, with backgrounds in epidemiology, mathematics, measurement, and statistics. We have acquired experience in large administrative, population-based cohorts and clinical trial databases, and in disease states including acute coronary syndromes, heart failure, and diabetes. Based on formal training and

experience, we can optimize many aspects of clinical research, from study design to analysis, and to the interpretation and conclusions of results. With the other members of the clinical research team, we help to achieve the equilibrium between statistical and clinical significance. We also have a unique opportunity to mentor the next generation of clinical investigators. Conveying an appreciation for statistics is important to the sustainability and advancement of clinical research. So too is the development and/or application of novel statistical techniques. At the CVC, we have used a variety of advanced techniques including multilevel modeling, dynamic risk modeling, gap-time modeling and weighted composite endpoints to address novel clinical questions. As 2013 draws to a close, so too does this formal celebration of statistics. However, as the digital platform (and collection of data) continues to broaden and pressures increase to conduct more efficient clinical research, the ability to translate raw data into meaningful information will continue to increase in value. The party must, and will, go on.

Selected CVC Presentations and Publications Since Last Issue Publications Stewart R, Claes Held C, Brown R, Vedin O, Hagstrom E, Lonn E, Armstrong P, Granger CB, Hochman J, Davies R, Soffer J, Wallentin L, White H. Physical activity in patients with stable coronary heart disease: an international perspective.. Eur Dianati Maleki N, Stocke K, Zheng Y, Westerhout Heart J in press http://dx.doi.org/10.1093eurheartj/ CM, Fu Y, Chaitman BR, Awad A, Armstrong PW. eht258. An assessment of ST-segment measurement Toma M, Ezekowitz JA, Bakal JA, O’Connor CM, variability between two core electrocardiogram Hernandez AF, Sardar MR, Zolty R, Massie BM, laboratories. Journal of Electrocardiography In press. Swedberg K, Armstrong PW, Starling RC. The relationship between left ventricular ejection Whellan D, Tricoci P, Chen E, Huang Z, Leibowitz fraction and mortality in patients with acute heart D, Pascal Vranckx P, Marhefka G, Held C, Nicolau failure: Insights from the ASCEND-HF Trial. Eur J J, Storey RF, Ruzyllo W, Huber K, Sinnaeve P, Weiss AT, Déry J-P, Moliterno D, Van de Werf F, Heart Fail in press. Armstrong PW, Califf RM. Data and Safety Monitoring Boards: Academic Credit Where Credit Is Due? JAMA 2013; 301:1563-4. http://dx .doi.org/10.1001/jama.2013.280383

Aylward P, White, H, Armstrong P, Wallentin L, Strony J, Harrington RA, Mahaffey KW. Vorapaxar in Acute Coronary Syndrome Patients Undergoing Coronary Artery Bypass Graft Surgery: Subgroup Analysis from the TRACER Trial. J Am Coll Cardiol. E pub ahead of print pii: S0735-1097(13)06018-X. 10.1016/j.jacc.2013.10.048

Hess CN, Schulte PJ, Newby LK, Steg PG, Dalby AJ, Schweiger MJ, Lewis BS, Armstrong PW, Califf RM, van de Werf F, Harrington RA. Duration of eptifibatide infusion after percutaneous coronary intervention and outcomes among high-risk patients with non-ST-segment elevation acute coronary syndrome: insights from EARLY ACS. Eur Heart J Acute Cardiovasc Care. 2013; 2(3):246-55. (PMID 24222836) http://dx.doi.org/10.1177/204 8872612474922

CVC HOLIDAY CLOSURE December 24, 2013 to January 1, 2014 Should any urgent issues arise, we encourage you to call the designated helpline for your study CVC’s main voicemail will be checked daily throughout the closure to address any important study-related issues.

CVC wishes you and your families the happiest of holidays.


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CANADIAN VIGOUR CENTRE

Address for Inquiries: 2-132 Li Ka Shing Centre for Health Research Innovation University of Alberta Edmonton, AB T6G 2E1 Canada Phone: 1-800-707-9098 Fax: (780) 492-0613 www.vigour.ualberta.ca

Publication Information This newsletter is published periodically as a service to Canadian investigational sites. The purpose is to provide information of interest to individuals involved in cardiovascular clinical trials managed by the Canadian VIGOUR Centre, University of Alberta in Edmonton, Alberta, Canada.

Selected CVC Presentations and Publications Since Last Issue Abstracts Ezekowitz JA, Welsh RC, Weiss D, Gubbels C, Brass N, Chan M, Keeble W, Khadour F, Knapp D, Sharma S, Sookram SS, Tymchak W, Westerhout CM, Armstrong PW. Providing Rapid Out Of Hospital Acute Cardiovascular Treatment (PRAOCT-3). Can J Cardiol 2013; 29 (10Suppl):S381-382. Abualnaja S, Podder M, Hernandez A, McMurray JJ, Armstrong PW, Ezekowitz JA. Does Atrial Fibrillation Affect Outcomes In Patients Admitted With Acute Heart Failure? Insights from the ASCEND-HF. Can J Cardiol 2013; 29 (10 Suppl):S147-148. Dianati-Maleki N, Van de Werf F, Goldstein P, Adgey J, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Armstrong PW. Incidence and Implications of Aborted Myocardial Infarction in STREAM. Circulation 2013;128: A9297. Dery JPP, Mahaffey K, Tricoci P, White H, Podder M, Moliterno D, Harrington R, Chen E, Strony J, Van de Werf F, Ziada KM, Held C, Aylward P, Armstrong PW, Rao S. Arterial access site and outcomes in patients undergoing percutaneous coronary intervention with or without vorapaxar. Circulation 2013;128: A10742. Jones S, Tricoci P, Huang Z, Moliterno DJ, Harrington RA, Sinnaeve P, Strony J, Van de Werf F, White HD, Held C, Armstrong PW, Aylward PE, Chen E, Patel MR, Mahaffey KW. Vorapaxar in Non–ST-Segment Elevation Acute Coronary Syndrome Patients with Peripheral Artery Disease: Results from TRACER. Circulation 2013; 128: A17939.

The VIGOUR (Virtual Coordinating Centre for Global Collaborative Cardiovascular Research) group is an international academic group committed to advancing cardiovascular medicine and enhancing patient care worldwide. Its membership includes: the Canadian VIGOUR Centre (CVC), University of Alberta, Edmonton, Alberta, Canada; Green Lane Coordinating Centre, Auckland, New Zealand; National Health & Medical Research Council – Clinical Trials Centre, Sydney, Australia; Flinders Medical Centre, Bedford Park, Australia; Duke Clinical Research Institute (DCRI), Duke University, Durham, NC, USA; Leuven Coordinating Centre, University Hospital Gasthuisberg, Leuven, Belgium; ECLA, Rosario, Argentina, South America; TANGO, Buenos Aires, Argentina, South America; Uppsala Clinical Research Centre, Uppsala, Sweden

Bernacki GM, Alexander KP, Newby LK, Yang Q, Schulte P, White HD, Ohman EM, Mahaffey KW, Shah BR, Giugliano RP, Armstrong PW, Harrington RA, Tricoci P, Van de Werf F, Alexander J, Califf RM. Lopes RD. Trends in Enrollment, Patient Characteristics, Treatments and Outcomes of Older Adults with Non-ST-segment Elevation Acute Coronary Syndromes (ACS) in Clinical Trials. Circulation 2013;128:A9904. Armaganijan L, Lopes R, Huang Z, Tricoci P, Held C, Van de Werf F, Armstrong PW, Aylward PE, White HD, Moliterno DJ, Wallentin L, Chen E, Harrington RA, Strony J, Mahaffey KW. Efficacy and Safety of Vorapaxar in Elderly Patients with Non–ST-Segment Elevation Acute Coronary Syndrome: Insights from the TRACER Trial. Circulation 2013;128: A13198. Tricoci P, Chen E, Neely ML, Warner A, Wong PH, Sinnaeve P, Wallentin L, Jennings LK, Storey RF, Aylward PE, White HD, Van de Werf F, Armstrong PW, Held C, Valgimigli M, Harrington RA, Strony J, Mahaffey KW, Moliterno DJ. CYP2C19 Polymorphism and PON-1 Activity in NSTE ACS: Vorapaxar Effect in Relation to Clopidogrel Metabolism in the TRACER Trial. Circulation 2013;128: A17658.

Bagai A, Huang Z, Lokhnygina Y, Harrington RA, Armstrong PW, Strony J, Chen E, White HD, Held C, Van de Werf F, Wallentin L, Tricoci P, Mahaffey KW. Differential Prognostic Implications of Peak Troponin Level in Acute Coronary Syndrome Treated With and Without Revascularization Circulation 2013;128:A14033. Halim S, Yang Q, Schulte P, Hochman J, Melloni C, Mahaffey KW, Moliterno DJ, Harrington RA, White HD, Armstrong PW, Ohman EM, Van de Werf F, Giugliano RP; Newby LK. Evolution of Differences in Women and Men with Non-ST-Segment Elevation Acute Coronary Syndromes: Insights from Clinical Trials over 15 years. Circulation 2013; 128: A15834. Welsh RC, Van de Werf F, Goldstein P, Gershlick AH, Wilcox R, Danays T, Bluhmki E, Westerhout CM, Armstrong PW. Impact of Rescue/Urgent Angiography on Outcomes of ST-Elevation Myocardial Infarction: Insights from STREAM. Circulation 2013;128:A17925. Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely ML, McGuire DK, Cornel JH, Huber K, Zamoryakhin D, White HD, Armstrong PW, Fox KA, Prabhakaran D, Ohman EM. Outcomes in Women Compared With Men in Patients With Unstable Angina/Non-ST-Segment Elevation Myocardial Infarction Managed Without Revascularization: Insights From the TRILOGY ACS Trial. Circulation 2013;128:A12130. Lopes RD, Neely B, Ohman EM, Ardissino D, Hamm C, Goodman SG, Bhatt DL, Brown EB, White HD, Prabhakaran D, Martinez F, Nicolau JC, Fox KA, Armstrong PW, Roe MT. Timing, Profile, and Predictors of Spontaneous Myocardial Infarction Following a Non-ST-Segment Elevation Acute Coronary Syndrome Event: Insights From the TRILOGY-ACS Trial. Circulation.2013;128:A14972. CVC gratefully acknowledges funding from the following: Alere Inc. Amylin Pharmaceuticals, LLC CSL Behring LLC GlaxoSmithKline Inc. Hoffmann-La Roche Merck & Co., Inc. Regado Biosciences Inc. Sanofi-aventis Recherche & Développement Canadian Institute of Health Research Mazankowski Alberta Heart Institute University Hospital Foundation Canadian Cardiac Chronicle Editorial Board: PW Armstrong Kalli Belseck Amanda Carapellucci Robert Evans Lyndsey Garritty Halina Nawrocki Jodi Parrotta

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Winter 2013 final