The Canadian Cardiac Chronicle Volume 18, No. 1
Spring 2014
Sometimes you just need to talk to people. So we did just that on Sunday, March 9th during a CVC sponsored clinical research colloquium held in Banff, Alberta in conjunction with the annual ACC Rockies Meeting. For some time we have been reflecting on the challenges facing our valued clinical research partners across Canada as it relates to continued participation in clinical trials. Last autumn we finally decided it was time to do some direct listening and learning. The concept was simple, namely to foster an open communication between our own academic research organization (CVC) and key community practicing site principal investigators and site coordinators. The aim was to generate productive dialogue that resulted in identification of key issues that restrict clinical trial involvement in Canada and develop strategies to overcome them. Once this concept was hatched and Tracy Temple agreed to organize it, I knew we were on the right track! We were fortunate to be able to generate both enthusiasm and unrestricted educational grant support from Amgen, Astra Zeneca, Merck and Sanofi-aventis that allowed us to hold the event this past month. We had an ambitious set of goals i] review major impediments to timely/efficient participation in clinical trials at the site level, ii] identify common issues that can be addressed collectively, iii] understand how best to add value to clinical trial experience at site level, iv] enhance our network of high performing sites (quality/quantity) and V] explore the potential for more common standard operating procedures (SOPs) in order to enhance Canada’s position in CV trials/ research. Because we reckoned there were differing trial “cultures” and correspondingly different needs for acute trials (e.g. acute coronary syndromes and heart failure) versus those involving secondary prevention (e.g. post ACS, diabetes and dyslipidemia) we decided to invite a spectrum of colleagues that represented those areas of research and also our geographic diversity. The CVC is proud to be a University of Alberta Centre
In This issue: Letter - P.W. Armstrong Trial Updates Monitoring CVC News CVC Publications
1 2-6 7 7 8
Key members of the CVC clinical trials coordinating team participated in this half day interactive session with both academic and community site principal investigators and coordinators in the presence of industrial medical representatives. All participants were required to complete a pre-meeting web-based survey that identified catalysts and barriers to the conduct of clinical trials in Canada. In conjunction with key, selected and brief presentations; the survey results were collated and presented at the half day interactive session. There was ample time for vigorous and open discussion and we committed to summarizing the discussion in a white paper that will accompany the next edition of the Chronicle. Although a formal evaluation is still in progress, the immediate feedback from both our invitees and sponsors was enthusiastically positive about the event. Specific action items emerged aimed at accelerating trial “startup times”, avoiding duplication and rationalizing SUSAR reporting. Each invitee is about to receive the overall survey result as well to be able to reflect on their views in this context. We look forward to sharing more learnings from this informative and rewarding networking event and engaging our other valued collaborators in the future. Stay tuned… With kind regards,
Paul W. Armstrong
The Canadian Cardiac Chronicle - Volume 18
IMPROVE-IT Welcome to the final year of the IMPROVE-IT trial! Because of your hard work over the last 8 years, the IMPROVE-IT trial is set to reach the protocol-defined number of primary events within the next few months. In preparation for this, on February 6th, 2014, Memo #410 announced the long-awaited Close-Out of the IMPROVE-IT study. Final study visits (face-to-face clinic visits) for all patients enrolled in IMPROVE-IT will begin on Thursday May 1st, 2014; booking of the final visits should begin now. Sites need to follow the booking schedule recommended in Memo #410 in order to have an unbiased, orderly closeout plan (something the regulatory agencies expect). Regular follow-up visits (clinic or phone) are to continue per protocol throughout March and April. Please Note the Following: • IVRS will be shut down on April 30th; therefore the May/ June final visits will not require a withdrawal call. • Lab Kit A should be used with COM (Completion) labels. Now is the time to ensure you have ample lab kits in stock (taking into account expiration dates), and order a resupply as needed. Additional COM labels will be provided to sites in April. • Sites will be asked to enter data within 1 day of each visit throughout the close-out period. This will allow DCRI data management to perform all data cleanup activities in a timely manner while visits are still ongoing.
Further details and guidance to ensure all protocol-required assessments are performed at the final visit are forthcoming. This will include source documentation forms for clinic visits as well as scripted phone visit instructions. For those of you who were in attendance at the ACC meetings this past week we hope you were able to attend the IMPROVE-IT combined Steering Committee and Investigator Meeting held on March 29th where we had the opportunity to share and discuss key operational and scientific aspects in preparation for completion of the trial. As a reminder, an email was sent to all sites on March 7th regarding the PR Status Reports (now called COSC Reports) for study drug. These 2 reports are to be printed and filed in your Investigator Site File (in the Drug Accountability Binder), as the monitors will be verifying that these reports are on site and filed appropriately. CEC Adjudicated Events – please remember to submit any outstanding (de-identified) source documents to the TIMI CEC at improveitcec@partners.org. 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.
IMProved Reduction of Outcomes: Vytorin Efficacy International Trial Sponsored by Merck & Co. Inc (previously ., Schering- Plough 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
PROACT This is an interesting community based project involving Edmonton Emergency Medical Services within the Edmonton metropolitan region and the Edmonton area Hospital Emergency Departments using point of care testing of troponins and BNP in the ambulance. We are excited to have reached the half way mark over the last month with 323 patients out of the projected 600 patients now recruited. The dedication and commitment of our EMS teams out in the field to this study has been tremendous and we thank them for their ongoing commitment to this study. Keep up the great work! For further information please contact Paula Priest at 1-800707-9098 (ext 9) or email at paula.priest@ualberta.ca. Page 2
Providing Rapid Out of Hospital Acute Cardiovascular Treatment
PROACT
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
The Canadian Cardiac Chronicle - Volume 18
EXSCEL our sites for your ongoing screening and enrollment efforts! Congratulations to our top 5 recruiting sites over the last 6 months:
The EXSCEL trial held a very informative and stimulating rejuvenation meeting this past January in Nashville. It was a great opportunity to meet with our wonderful sites and share our successes and gain insights on the EXSCEL trial. We also learned of the upcoming protocol Amendment 5 which is soon to be released in Canada. Health Canada approval of this amendment is expected by the end of March 2014. There will also be a number of new and exciting patient and site materials released with the Amendment 5 regulatory package. We are confident that these will be great tools to aid in your efforts towards successful patient retention. To date our Canadian sites have done a tremendous job with patient retention and we are happy to report that Canada has no patients lost to follow up – a big thank you to all of our sites for fostering solid relationships and ensuring ongoing communication with their patients! Recruitment continues to increase with over 9,000 patients enrolled worldwide, and almost 400 in Canada. Thank you to all
PI Dr. Francois Dubé – SC Marilène Bolduc – 10 patients enrolled PI Dr. Robin Kuritzky – SC Carol Marchand – 8 patients enrolled PI Dr. Heather Lochnan – SC Denise DeCurtis – 8 patients enrolled PI Dr. Zubin Punthakee – SC Irene Stanton – 6 patients enrolled PI Dr. Jean-Francois Yale – SC Angela Lombardo – 6 patients enrolled We look forward to activating several new sites in Canada over the next few months. Should you be interested in participating in the EXSCEL trial or would like further information, please contact Clinical Trial Project Lead Amanda Carapellucci at 1-800-707-9098 (ext. 2) or by email at amanda.carapellucci@ ualberta.ca or Diane Camara at 1-800-725-6585 or by email at dcamara@chrc.net. Exenatide Study of Cardiovascular Event Lowering Sponsored by Bristol-Myers Squibb, 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
TECOS This is an exciting time for the TECOS study as we are now actively preparing for study completion and closeout in the months to come. It’s time to dust off your eCRF manuals, regulatory binders, monitoring follow-up letters, and drug accountability logs and start spring clean-up at your site. We are pushing for everyone to actively stay on top of your data and ensure you are closing all queries and entering your visits within a few days of your study visits. This will ensure that there is no backlog of data at your site as we head into closeout and will enable us to quickly address outstanding issues and close the database. As a reminder, if you have any outstanding documents that need to be submitted to CEC, please do so as quickly as possible. Congratulations to Dr. Richard Dumas and Sylvie Gauthier’s site in Laval, QC and Dr. Kevin Saunders and Lori Richert’s site in Winnipeg, MB who as of March 18th have 100% clean data.
submitted to ethics and receive approval please forward your ethics submission and approval letters to Tracy and Kalli at CVC for your site regulatory file along with the other required regulatory documents. Since your monitors are only on site for a short time when they come to visit, please ensure your data, regulatory documents, drug accountability and other key items are up to date so they can utilize their time most effectively while on site and help answer any questions you may have. As we near the finish line we will be in close contact, and look forward to sharing the end result of your hard work! If you have any questions please don’t hesitate to contact Tracy Temple, Assistant Director - Clinical Trials at tracy.temple@ ualberta.ca or Kalli Belseck at kalli@ualberta.ca or by phone at 1-800-707-9098.
We are also pleased to have 25/26 of our sites in Canada with over 96% of their data clean. Keep up the great work! We will be pushing to get everyone close to 100% clean this month so please help us out by staying on top of your data each week. You should have recently received Amendment 3 and Amendment 4 for submission to ethics. As a reminder these amendments do not require ICF changes so once you have Page 3
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
The Canadian Cardiac Chronicle - Volume 18
REGULATE-PCI REGULATE-PCI had its second US Investigator Meeting in February in Miami. It was a very interactive meeting and a great opportunity to meet face-to-face with each other while learning about the protocol and the study drug. Certificates will be created and sent to all attendees, documenting their protocol training. Please print and file these certificates in your Investigator Site File (in the Training tab). The study is now underway world-wide with over 950 patients enrolled at 79 sites in 16 countries across North America and Europe. In Canada, we have 92 patients enrolled from 5 sites: • • • • •
Dr. Cantor (Newmarket, ON) – 70 patients Dr. Charbonneau (Calgary, AB) – 7 patients Dr. Fung (Vancouver, BC) – 5 patients Dr. Mehta (Hamilton, ON) – 3 patients Dr. Vo (Winnipeg, MB) – 3 patients
We continue to work hard on study start-up activities with the remaining sites, and look forward to getting them activated in the next couple of months. Amendment 1.1 (version 2.1) was sent to sites on February 18th and the NOL letter was recently received from Health Canada and distributed to all sites. Once your site has obtained and provided CVC with a copy of your ethics approval for the amended protocol and ICF, along with your protocol signature page, documentation of training and REBA (as required), CVC will notify you about the commencement date (i.e., when you are able to implement the amendment). For further information, or if you are interested in participating, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800707-9098, ext. 3 or by email at jodi.parrotta@ualberta.ca. Sponsored by Regado Biosciences Inc. this is a randomized, open-label, multi-center, active-controlled, parallel group study to determine the efficacy and safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention
Dr. Dr. Cantor’s site continues to excel! They remain the highest enroller in Canada, and hold the title of second highest enroller globally! In March, two more sites were activated in Canada: Dr. Welsh (Edmonton, AB) and Dr. Della Siega (Victoria, BC). We look forward to these two sites enrolling their first patients in the coming weeks.
Clinical trials.gov Identifier: NCT01848106
AEGIS-I We have been actively working through site feasibility and selection over the last couple months and will be looking for a few additional sites to participate in this new phase 2b study investigating the safety and tolerability of multiple IV dose administration of CSL112 in patients with acute myocardial infarction with the intent to decrease recurrent cardiovascular events by reducing and/or stabilizing atherosclerotic plaque. CSL 112 is a novel formulation of apolipoprotein A-I (ApoA-I), purified from plasma and reconstituted to form high-density lipoprotein (HDL).
studies and are interested in hearing more about this study please contact Tracy Temple at 1-800-707-9098 Option 5 or by email at tracy.temple@ualberta.ca.
The submission to Health Canada is expected to occur over the next few weeks and as we complete the remaining site selection visits we will be actively moving into study start up. The CVC will be responsible for site/project management and monitoring of the Canadian sites in this study and is working closely with the sponsor, DCRI, PERFUSE, Stanford and Quintiles on this project. If you are a site with experience in Phase 2 Page 4
Sponsored by CSL Behring LLC, this study is a Phase 2b, multicenter, randomized,placebo-controlled, dose-ranging study to investigate the safety and tolerability of multiple dose administration of CSL112 in subjects with acute myocardial infarction.
The Canadian Cardiac Chronicle - Volume 18
ODYSSEY OUTCOMES PI Dr. Vizel – SC Glorita Markov – 4 Patients Screened Our top enrollers as of March 2014 are:
Thanks to all the ODYSSEY study coordinators who attended the March meeting in Orlando!
2014 will be a busy and exciting year for the ODYSSEY Outcomes trial in Canada. Worldwide the trial has screened almost 9000 patients with Canada contributing over 170 patients to this current total. As we continue to bring new sites on board and begin to implement Amendment 6, we anticipate a large boost in screening and enrollment activity across the country. Amendment 6 received Health Canada approval in late February. We look forward to beginning to activate sites under the amended protocol in the coming months. To that end, please confirm that all of the required regulatory documents, as well as the required protocol amendment training have been completed by your site. If you have not already done so, please ensure that your revised Informed Consent Forms have been submitted to the CVC for approval prior to submission to your local REB. Thank you to all sites who are actively pre-screening, screening, and enrolling patients into the ODYSSEY Outcomes trial! Big congratulations go to our top screening sites for the months of January 2014 – March 2014:
PI Dr. Manahora Senaratne – SC Bernadette Fernando – 6 Patients Randomized PI Dr. Christopher Lai – SC Cindy Cyderman – 4 Patients Randomized PI Dr. Jan Kornder – SC Lynn Breakwell/Dale Kastanis – 4 Patients Randomized PI Dr. Tycho Vuurmans – SC Carol Marchand – 3 Patients Randomized Your efforts are much appreciated! It was nice to meet many of the Canadian ODYSSEY Outcomes Study Coordinators face to face at the recent meeting in Orlando. This was a great opportunity to discuss the Amendment 6 updates/changes, as well as share experiences and network with other coordinators. Hopefully everyone caught a few rays of sun while they were there. We are still recruiting a few final sites for this study. Should you be 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. Sponsored by Sanofi-aventis 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.
PI Dr. Senaratne – SC Bernadette Fernando – 6 Patients Screened PI Dr. Savard – SC Gina Vincelli – 5 Patients Screened PI Dr. Sussex – SC Jill Cole – 5 Patients Screened PI Dr. Lai – SC Cindy Cyderman – 4 Patients Screened
ClinicalTrials.gov Identifier: NCT01663402
SODIUM-HF SODIUM-HF is an exciting Phase III trial which 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.
If you have questions about the dietary intervention components, please contact Melisa and she will connect you with the trial dietitian.
Over 15 sites across Canada are working through start-up. A big shout out to all participating sites - your efforts in getting up and going are appreciated. Thank you and keep up the great work!
If you are interested in participating in SODIUM-HF or would like further information, please contact Clinical Trial Project Lead Melisa Spaling at 780-492-8476 or via email at mspaling@ ualberta.ca
Congratulations to Dr. Ezekowitz and Dr. Eloisa Colin (SODIUM-HF dietitian) on being the first site activated and enrolling their first 2 subjects in the SODIUM-HF trial! We anticipate a number of sites will be activated in the next few weeks and will continue to work closely with you to ensure your site is ready for activation. Please remember that training on the dietary intervention, protocol, and eCRF must be completed prior to activation.
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. ClinicalTrials.gov Identifier: NCT02012179
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The Canadian Cardiac Chronicle - Volume 18
GUIDE-IT All 6 Canadian sites are active and enrolling subjects! In North America, there are 231 subjects enrolled (Canada = 21) and 39 enrolling sites. Welcome Dr. Andrew Grant, new PI at University of Calgary/ Foothills Hospital as of March 17th! Thank you Dr. Patricia Campbell, for your leadership and support of GUIDE-IT during your role as PI at this site.
the 90% target and our sites query response times are half that of the trial average! Thank you and please stay on top of your data entry and queries. If you have questions or concerns about data entry or any pesky queries, please contact your Project Lead – we will work together to sort it out.
Congratulations to Dr. Patricia Campbell, Kim Ronak & Sheilah Heal at the University of Calgary/Foothills Hospital for enrolling 4 patients in 5 weeks!
Please continue to complete your screening logs – these should be sent to Melisa every week. These logs are helpful in assisting the operations team with identifying challenges in enrollment. If your site has REB approval for Amendment 2, please use the revised screening log for this amendment to reflect the adjustments made in the inclusion/exclusion criteria.
Congratulations to Dr. Gordon Moe, Carlos Fernando, & Andrea Konig for being the Canadian site to enroll the soonest after activation (< 3 weeks)!
Thank you to all GUIDE-IT sites for your commitment to this important heart failure study. We look forward to continued collaboration on this trial!
Thank you to all sites for submitting Protocol Amendment 2 to your REB so quickly. The revisions to the inclusion/exclusion criteria and greater flexibility with the 2-week follow up visits should provide a wider range of eligible patients. Of the 6 Canadian sites, 4 are now enrolling under Amendment 2. Don’t forget to forward your Amendment 2 training log, along with your REB approval documents, to your Project Lead.
For further information, please contact Clinical Trial Project Lead Melisa Spaling at mspaling@ualberta.ca or direct: 1-780492-8476.
Many thanks to all Study Coordinators for your diligent efforts in completing and cleaning your data for the March DSMB meeting. All Canadian sites have data completion rates above
In collaboration with DCRI (Duke Clinical Research Institute) and Roche GUIDE-IT is a prospective, randomized 1:1, multi-centre clinical trial GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure ClinicalTrials.gov Identifier: NCT01685840
STABILITY The full results of the STABILITY trial were presented at the late breaking clinical trial session during the American College of Cardiology meetings in Washington, DC on Sunday morning, March 30th, 2014, by study Co-Chair Dr. Harvey White. For our investigators and coordinators in attendance at the ACC meetings there was also an opportunity to attend a closed session the night before. It was nice to see a few familiar Canadian faces in the crowd. As you know from the earlier press release the study did not reduce the incidence of the primary composite endpoint of CV death, MI or stroke. Further conclusions presented at the ACC meeting showed there was no effect on stroke or total mortality and darapladib reduced the pre-specified coronary-specific secondary endpoints of major coronary events (1% absolute) and total coronary events (1.5% absolute) with nominal significance (p<0.05). Further analysis on the subgroups of patients in this study will be done to determine if darapladib
may be useful in subsets of patients. These results were simultaneously published and are now available in the NEJM. All STABILITY sites should have received a CD(s) with site specific eCRF data over the last month. If you have not received or have trouble accessing your CD and/or password, please let us know so we can work with you. It has been nice to work with all of you on this study and once again we would like to thank you for all your hard work to get to the finish line. If you have any questions please don’t hesitate to contact Tracy Temple, Assistant Director – Clinical Trials at tracy.temple@ualberta.ca or by phone at 1-800-707-9098 Option 5.
STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY Sponsored by Glaxo SmithKline Inc., this trial is a randomized, placebo-controlled, 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
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The Canadian Cardiac Chronicle - Volume 18
Monitoring Tips It’s time to get prepared! Here are a couple key tips that the Health Canada Inspector will review and be looking for in a site inspection.
Apart from the above SOPs, the inspector looks for documentation of GCP and Division 5 training for all staff involved in the protocol that they have come to inspect.
In addition to the review of the protocol, the inspectors also focus on the research centre’s processes and procedures. This involves reviewing your site Standard Operating Procedures (SOPs), ICH GCP, and Health Canada Division 5 training.
If you don’t have these in place at your site, it is time to get this done now - not when you get the call that the inspector is coming.
Your SOPs should have at a minimum a process written for: 1. Consent and consent process 2. Documentation of capturing AE/SAEs; investigator review and submission timelines to the sponsor and REB 3. Study drug storage, accountability and destruction 4. Record retention 5. Calibration and maintenance records for all research equipment 6. Staff training on the SOPs and documentation of this training
CVC News Melisa Spaling joined CVC in October, 2013 to manage the SODIUM-HF, GUIDE-IT and VITA-HF trials. Her several years of experience in coordinating health research studies, especially heart failure research, with the University of Alberta and Alberta Health Services are a valuable asset to the CVC team.
We would like to take this opportunity to introduce you to Ken Iledan who has recently joined our monitoring team. Ken has a Bachelor of Science in Nursing (BScN) and recently immigrated to Canada from the Philippines where he worked as a CRA and Study Start-up Manager. He will be working closely with Halina Nawrocki, our Lead CRA over the next couple months and will be visiting a number of our EXSCEL trial sites.
Ellen Pyear joined the CVC Business Office in a support role in November 2013. She recently completed her MA in Art History at Carleton University in Ottawa. Ellen has several years of experience in research and administration, and has worked in both the public and private sector. In February 2014 members of the CVC staff participated in Go Red for Women - a movement in support of raising awareness about heart disease in women Page 7
The Canadian Cardiac Chronicle - Volume 18
Publications Reed SD, Kaul P, Li Y, Eapen ZJ, Davidson-Ray L, Schulman KA, Massie BM, Armstrong PW, Starling RC, O’Connor CM, Hernandez AF, Califf RM. Medical Resource Use, Costs, and Quality of Life in Patients With Acute Decompensated Heart Failure: Findings From ASCEND-HF. J Cardiac Failure. 201;19(9):611-20. PMID: 24054337, http://dx.doi.org/10.1016/j.cardfail.2013.07.003 Bagai A, White JA, Lokhnygina Y, Giugliano RP, Van de Werf F, Montalescot G, Armstrong PW, Tricoci P, Gibson CM, Califf RM, Harrington RA, Newby LK. Routine early eptifibatide versus delayed provisional use at percutaneous coronary intervention in high-risk non-ST-segment elevation acute coronary syndromes patients: an analysis from the Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome trial. (EARLY-ACS) Am Heart J. 2013;166(3):466-73. PMID: 24016495, http://dx.doi.org/10.1016/j. ahj.2013.05.019 Howlett JG, Ezekowitz JA, Podder M, Hernandez AF, Diaz R, Dickstein K, Dunlap ME, Corbalán R. Armstrong PW, Starling RC, O’Connor CM, Califf RM, Fonarow GC; on behalf of the ASCEND-HF Investigators. Global Variation in Quality of Care Among Patients Hospitalized With Acute Heart Failure in an International Trial Findings From the Acute Study Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial (ASCEND-HF). Circ Cardiovasc Qual Outcomes. 2013; 6(5): 534-42. PMID: 23899930, http://dx.doi.org/10.1161/ CIRCOUTCOMES.113.000119 Bagai A, Armstrong PW, Stebbins A, Mahaffey KW, Hochman JS, Weaver WD, Patel MR, Granger CB, Lopes RD. Prognostic implications of left ventricular end diastolic pressure during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Findings from the APEX-AMI study. Am Heart J 166(5):913-9. PMID: 24176448, http://dx.doi.org/10.1016/j. ahj.2013.08.006 Eggers KM, Armstrong PW, Califf RM, Johnston N, Simoons ML, Venge P, James SK. Clinical and prognostic implications of circulating pentraxin 3 levels in non ST-elevation acute coronary syndrome. Clin Biochem. 2013 Sep 5. [Epub ahead of print] PMID: 24012697, http://www.sciencedirect.com/science/article/pii/ S0009912013003937
Elevation Acute Coronary Syndrome (from the EARLY ACS Trial). Am J Cardiol. 2014 . pii: S0002-9149(14)00541-4. [Epub ahead of print] PMID: 24607027, http://www.ncbi.nlm.nih.gov/pubmed/24607027 Held C, Tricoci P, Huang Z, Van de Werf F, White HD, Armstrong PW, Ambrosio G, Aylward PE, Moliterno DJ, Wallentin L, Chen E, Erkan A, Jiang L, Strony J, Harrington RA, Mahaffey KW. Vorapaxar, a platelet thrombin-receptor antagonist, in medically managed patients with non-ST-segment elevation acute coronary syndrome: results from the TRACER trial. . Eur Heart J Acute Cardiovasc Care. 2014 Mar 13. [Epub ahead of print] PMID: 24627331, http:// www.ncbi.nlm.nih.gov/pubmed/24627331 Dianati Maleki N, Stocke K, Zheng Y, Westerhout CM, Fu Y, Chaitman BR, Awad A, Jagasia P, Armstrong PW. An assessment of ST-segment measurement variability between two core electrocardiogram laboratories. J Electrocardiol. 2014;47(1):38-44. Epub 2013 Oct 18. PMID: 24246251, http://www.ncbi.nlm. nih.gov/pubmed/24246251 Mahaffey KW, Huang Z, Wallentin L, Storey RF, Jennings LK, Tricoci P, White HD, Armstrong PW, Aylward PE, Moliterno DJ, Van de Werf F, Chen E, Leonardi S, Rorick T, Held C, Strony J, Harrington RA. Association of Aspirin Dose and Vorapaxar Safety and Efficacy in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (from the TRACER Trial). Am J Cardiol. 2014;113(6):93644. Epub 2013 Dec 25. PMID: 24444781, http://www.ncbi.nlm.nih.gov/ pubmed/24444781 Toma M, Ezekowitz JA, Bakal JA, O’Connor CM, Hernandez AF, Sardar MR, Zolty R, Massie BM, Swedberg K,Armstrong PW, Starling RC. The relationship between left ventricular ejection fraction and mortality in patients with acute heart failure: insights from the ASCEND-HF Trial. Eur J Heart Fail. 2014;16(3):33441. Epub 2013 Dec 14. PMID: 24464687, http://www.ncbi.nlm.nih.gov/ pubmed/24464687
Calvo G, McMurray JJV, Granger CB, Alonso-Gracia A, Armstrong P, Flather M, Gómez-Outes A, Pocock S, Stockbridge N, Svensson A, Van de Werf F. Large streamlined trials in cardiovascular disease. Eur Heart J e-publication, http:// dx.doi.org/10.1093/eurheartj/eht535 Kunadian V, Giugliano RP, Newby LK, Zorkun C, Guo J, Bagai A, Montalescot G, Braunwald E, Califf RM, Van de Werf F, Armstrong PW, Harrington R, Gibson CM.Angiographic Outcomes With Early Eptifibatide Therapy in Non-ST-Segment 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. 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 Address for Inquiries: 2-132 Li Ka Shing Centre for Health Research Innovation University of Alberta, Edmonton, AB, Canada, T6G 2E1 Phone: 1-800-707-9098, Fax: (780) 492-0613 www.vigour.ualberta.ca
CVC gratefully acknowledges funding from the following: Alere Inc. Bristol-Myers Squibb CSL Behring LLC GlaxoSmithKline Inc. Hoffmann-La Roche Merck & Co., Inc. Regado Biosciences Inc. Roche Diagnostics Operations Inc. Sanofi-aventis Recherche & Développement Canadian Institute of Health Research Mazankowski Alberta Heart Institute University Hospital Foundation Canadian Cardiac Chronicle Editorial Board: Paul W. Armstrong Kalli Belseck Amanda Carapellucci Halina Nawrocki
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Jodi Parrotta Dianne Payeur Carla Price Paula Priest
Ellen Pyear Melisa Spaling Tracy Temple