Winter 2011 by Canadian VIGOUR Centre

CANADIAN VIGOUR CENTRE

Bridging hearts and minds to enhance cardiovascular care

Inside this issue: Letter - PW Armstrong

Trial Updates

2-5

How to 6 Address Common Health Canada Inspections Findings Preparing for a Monitoring Visit

CVC Publications

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The Canadian Cardiac Chronicle

Volume 15, No. 2

Winter 2011

Letter from Dr. Paul Armstrong The rapidly advancing wave of information technology and communication through the internet has raised in the minds of many the value of major scientific/medical meetings such as the American Heart Association recently held in Orlando. If even the major results as well as the integrated analysis of invited discussants are posted on the web prior to the actual presentations themselves, is there any reason to be physically in attendance? For me, physical attendance and participation in these meetings is indispensable. Remotely accessing this information indirectly may seem adequate to some but falls short of the mark for many including myself. In the same vein, being physically present at a sporting event where the electricity and chemistry are up close and personal versus watching it on the television set constitutes a reasonable analogy. The hallway dialogue and over-dinner discussions remain key “behind the scenes” opportunities to undertake a reality check on both the assets and liabilities of recently reported findings. Moreover, the implications of these fresh new data, as they relate to work in progress, as well as that still on the drawing board but not yet implemented, can be far reaching. Steering committee meetings, advisory board discussions, planning for future scientific presentations and publications and social networking with our valued collaborators in industry and academia worldwide are all part of the rich opportunities for coming together at the AHA. This year, the depth, breadth and diversity of cardiovascular science were breathtaking. Moreover, the poster and free oral communication sessions (when there is time to attend them) allow welcome name-face recognition and reality checks on credibility and the state of preparedness of various research initiatives. Also and often underestimated is the enormous opportunity provided by those “under the radar” individuals who contribute so much to the success of academic research organizations. These include personnel in the key project/operations areas, the indispensable biostatistical underpinnings of clinical research, the contract/ financial infrastructure: all are fundamentally necessary to set the table for optimal collaborative research. Finally, the opportunities to assist in career development of those in training and beginning their faculty careers are another key element at meetings like the AHA. The bonds of friendship are strengthened by the warmth of dinnertime conversations removed from the slings and arrows of local worries. It is from all of these personal interactions that many good things can and do regularly happen. As the calendar year 2011 draws to a close and on behalf of all of our faculty and staff at the Canadian VIGOUR Centre, let me extend our warmest wishes for a peaceful holiday season and a happy New Year.

CVC is proud to be a University of Alberta Centre

www.vigour.ualberta.ca

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The Canadian Cardiac Chronicle

IMPROVE IT

IMProved Reduction of Outcomes:Vytorin Efficacy Trial — International IMPROVE IT 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

Operation “Retain” is underway for the IMPROVE IT Study. Recently, retention materials were distributed to sites to help you retain your ongoing subjects and reconnect with (and hopefully) re-engage subjects who have either been classified as lost to follow up or withdrawn from the study. It is the goal of the study to have zero subjects lost to follow up and to have a token number of truly “withdrawn” consent subjects. The importance of maintaining subjects on study drug and collecting key outcomes data on all subjects randomized in a clinical trial, regardless of study drug therapy status, is an issue that regulatory agencies globally are scrutinizing. The FDA has a guidance document on subject retention that can be found at : http://www.hhs.gov/ohrp/policy/ subjectwithdrawal.html The recent data deadline to have all Clinical Events Committee documentation submitted was December 2, 2011. Thank you to all who worked hard to ensure that your supporting documentation was completed and that all CEC queries were resolved. Timely data completion and query resolution should be on your weekly “to do” list. The longer a query is left, the harder it can be to

resolve. Don’t avoid looking at your data and hope it will go away! We are always more than happy to work through your data issues with you over the telephone. A big shout out to the following sites for 100% site clean data (as of November 28, 2011). • Dr. G. Gosselin, Margaux David from Centre Hospitalier Pierre-Le Gardeur – Terrebonne, QC • Dr. S. Kouz, Madeleine Roy from Centre Hospitalier Regional de Lanaudiere - St. Charles Borromee, QC • Dr. F. Grondin, Noella Bilodeau from Hotel Dieu de Levis – Levis, QC • Dr. R. Haichin, Violeta Toyota from Royal Victoria Hospital – Montreal, QC • Dr. C.V. Kieu, Massimo Forgione from CSSS Richelieu Yamaska C.H. Honore Mercier, St. Hyacinthe, QC • Dr. A. Mukherjee, Kim Brown from Scarborough Cardiology Research, Scarborough, ON We wish everyone a peaceful and relaxing holiday season and all the best in 2012. For further information, please contact Monica Adam or Courtney Bryden at 1‐800‐707‐9098 (option 2) or email at monica.adam@ualberta.ca or courtney.bryden@ualberta.ca.

REGADO OHS

REGADO OHS Sponsored by Regado Biosciences Inc. this is a phase 2a, multicenter, open‐ label, randomized, feasibility and safety study comparing the REG1 anticoagulation system with unfractionated heparin plus protamine in subjects who are undergoing either on‐pump isolated valve replacement or repair, or elective on‐pump coronary artery bypass.

We are pleased to be collaborating with Regado Biosciences Inc. on this small Phase IIa feasibility study, using the REG1 system in patients undergoing open heart surgery. This involves a new therapeutic technology using a two-component drug system; each system comprises an RNA aptamer that can be controlled directly by its specific and complimentary mirror image. We recently met with potential Canadian investigators in October, during the time of the Canadian Cardiovascular Society meetings, and plan to have three to four sites participating from Canada. Dr. Stephen Fremes from Sunnybrook Health Sciences in Toronto will be working with us as the National Coordinator. We are currently awaiting Health Canada approval and expect to be actively working with our sites to get them through the start up phase with the hope of having the first patient enrolled in April 2012. If you have any questions regarding or interest

in the REGADO OHS study, please contact Tracy Temple by telephone at 1-800-707-9098 (Option 2) or by email at tracy.temple@ualberta.ca

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Volume 15, No. 2

EXSCEL EXSCEL is a multinational pragmatic trial that will be conducted at approximately 400 sites worldwide and include an anticipated 9500 patients. This trial is designed to compare the impact of exenatide, a GLP-1 analogue formulated in a once-weekly, subcutaneous injection in patients with type 2 diabetes. Usual care will be provided to the comparative group and exenatide added to the treatment group with an examination of major CV outcomes including CV-related death, non-fatal myocardial infarction, or non-fatal stroke. Eligible patients will have type 2 diabetes with an HbA1c ≥7.0 % and ≤10.0 % on stable doses of up to three oral antihyperglycemic agents for at least 3 months. Patients enrolled will be at a wide range of CV risk with approximately 60% having had a prior CV event. We have received Health Canada approval and will be contacting sites shortly to participate in Canada. We are hoping to move sites quickly through the start up process with a planned first patient in Canada in early 2012. We are pleased that Dr. Shaun Goodman will play a lead role in Canada on the Operations Committee and, in collaboration with the CVC, he and his team will

manage this trial across Canada.

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

Recruitment has been ongoing in the US for over a year with sites just coming up in the rest of world. Enrollment is currently close to 1500 patients. If you are interested in hearing more about this trial please contact Courtney Bryden at courtney.bryden@ualberta.ca or 1-800-707-9098 Option 2.

STABILITY The main focus for STABILITY remains patient retention. Your efforts to keep patients involved in the trial remains very important. As you know, there have been several patient retention initiatives. If you have not already done so, please be sure to submit the most recent patient retention materials, including the October 2011 newsletter, cookbooks, and the 2012 Patient Calendar to your ethics committee for approval. All of our sites should have received a save-thedate for one of the upcoming STABILITY Booster meetings (EAST - Arlington, VA- May 2/3, 2012 and WEST - Dallas, TX – April 24/25, 2012) in the spring. Please make sure you have marked your calendars. Invitations will be sent out in the new year. As a reminder, please be sure to forward a copy of any ethics approvals or correspondence to our attention at the CVC for your regulatory file. Additionally, please check to see when your ethics annual renewals are due so you can be sure to submit those in advance. Finally, if you have received updated medical licenses, REB membership rosters and/or lab

accreditation certificates, please remember to forward a copy of those to CVC and keep a copy in your regulatory file. Please keep an eye out for the updated Study Procedures Manual which will be distributed in December as well as the next round of Standard of Care Reports expected early in the new year. For further information regarding the STABILITY study, please contact Tracy Temple or Valencia Galbraith at 1-800-707-9098 (Option 2) or via email at tracy.temple@ualberta.ca or valencia.galbraith@ualberta.ca

Sponsored by Glaxo SmithKline, the STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY (STABILITY) 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

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The Canadian Cardiac Chronicle

TECOS

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 on Mono‐ or Dual Combination Oral Antihyperglycemic Therapy

Global enrollment for TECOS is currently at 10,070 of the 14,000 patient sample size expected by May 31, 2012. With the end of enrollment drawing near we are very focused on boosting enrolment numbers to ensure that monthly and overall projections are met. Canada has been doing well and we have exceeded our overall enrollment projections expected for this point in the study. Let’s keep this momentum going! Canadian enrollment is at 406 patients and we must enrolll at least 481 patients by May 2012 – this means our sites need to recruit a minimum of 15 patients per month for the next 5 months. There is a study-wide challenge set forth to each site to enroll at least one patient each month. All Canadian sites that meet this challenge will receive a special honorary mention within our TECOS Newsletters and also in the CVC Chronicle. Sites with 1 Pt/Month for the last 3 Months: • Dr. Laurie Mereu & Bonnie Woloschuk: University of Alberta Hospital, Edmonton, AB • Dr. A. Shekhar Pandey & Monica Byrne: Cambridge Cardiac Care Centre, Cambridge, ON • Dr. Pierre Filteau & Kimberly Berube: Centre Medical des Carrières, Saint-Marc-des-Carrières, QC • Dr. Yves Robitaille & Cynthia Tremblay: CSSS du Sud de Lanaudière –

STrategic Reperfusion Early After Myocardial Infarction— STREAM Sponsored by Boehringer Ingelheim* this trial is a comparison of the efficacy and safety of a strategy of early fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catherisation within 6‐24 hours or rescue coronary intervention versus a strategy of standard primary PCI in patients with acute myocardial infarction within 3 hours of onset of symptoms. * Additional support provided by Roche Canada

Hôpital Pierre-Le Gardeur, Terrebonne, QC • Dr. Andre Carpentier & Francine Lapointe: Centre Hospitalier Universitaire de Sherbrooke – Hôpital Fleurimont, Sherbrooke, QC Please remember to continue sending in your Screening Logs bi-monthly! Overall, eCRF data for Canada consistently hovers around the 90% clean mark for expected visits. While the protocol-specified goal is to maintain >90% clean data at all times, many countries involved in TECOS have surpassed this mark. Please ensure that your data is entered within two days of each study visit so Canada can be one of the front-runners for data clean status! THANK YOU to our two top enrollers for their significant contributions to TECOS thus far! • Dr. Jan Kornder & Tracy Cleveland: Surrey Memorial Hospital, Surrey, BC – 28 patients • Dr. Jean-Louis Chiasson & Helene Langelier: CHUM - Hôtel Dieu, Montreal, QC – 28 patients For further information, please contact Tracy Temple or Lyndsey Garritty at 1-800-707-9098 (Option 2) or via email at tracy.temple@ualberta.ca or lyndsey.garritty@ualberta.ca

STREAM Global Enrollment is currently 1579. We are in the final stretch for recruitment and anticipate that the goal of 2000 subjects will be reached halfway through 2012.

documentation of training for all study personnel is critical. Please ensure that your training documents are reviewed and are in order.

Thank you to our sites for responding to the request to comb through old records for “missing” ECGs and re-uploading them into the eCRF. All ECGs are critical for the evaluation of STREAM and for complete and accurate study results.

Data completion is always a focus for a study. Please ensure that any Serious Adverse Events, 30-day and one-year follow ups are signed by the Principal Investigator in a timely fashion. If you require any assistance identifying data that needs to be signed off, please do not hesitate to call CVC.

The findings from recent Health Canada Inspections indicate that complete and timely

Happy Holidays to you and yours and all the best for 2012. For more information, please contact Monica Adam at 1-800-707-9098 (Option 2) or email at monica.adam@ualberta.ca.

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Volume 15, No. 2

TRACER As we wind down activities on TRACER, we would like to take this opportunity to thank each of our sites for their hard work and dedication to this trial over the last four years. As you know, the TRACER results were recently presented at the American Heart Association Meetings in Orlando during the late-breaking clinical trials session on November 13, 2011. We would like to thank those of you who took the time to join us on Saturday, November 12, 2011 for the Investigator Results Presentation. It was nice to see some familiar faces in the crowd. Published in the New England Journal of Medicine on November 13, 2011, the results showed: When added to standard of care in patients with NSTE ACS and high use of aspirin and P2Y12 inhibition, vorapaxar: • Did not significantly reduce the composite of CV death, MI, stroke, hospitalization for ischemia, or urgent revascularization. • Reduced CV death, MI or stroke. • Significantly increased bleeding, including major bleeding, and intracranial hemorrhage

awaited with much interest and is expected to be presented at the American College of Cardiology meetings in Chicago in March 2012. With all closeout visits now complete, we have been busy sorting through the documentation that has come in. Our goal is to have all files cleaned up before the end of the year, so we would greatly appreciate your help in responding to and closing out any final requests we send your way as quickly as possible. For further information regarding the TRACER study, please contact Tracy Temple or Valencia Galbraith by telephone at 1-800-707-9098 (Option 2) or by email at tracy.temple@ualberta.ca or valencia.galbraith@ualberta.ca.

Sponsored by Merck & Co. Inc., (previously Schering‐ Plough Research Institute), this trial is a multicenter, randomized, double‐blind, placebo‐controlled study evaluating the safety and efficacy of adding a new thrombin receptor antagonist to the standard of care for a minimum of 1 year in patients with non‐ST‐ segment elevation acute coronary syndrome.

In reflecting on these results and the balance of efficacy and risk, the second of the pair of large Phase III studies with vorapaxar (TRA-2P) is

PROACT—A local initiative Novel Proximal Pathways for Non-ST-Elevation Myocardial Infarction and Acute Heart Failure An Edmonton-region project initiated by Dr. Paul Armstrong, Dr. Justin Ezekowitz and Dr. Robert Welsh entitled PROACT is currently underway. PROACT is a randomized controlled trial designed to assess how the early diagnosis and risk stratification acquired through pre-hospital point of care biomarkers and paramedic assessment will facilitate enhanced triage and treatment in patients with presumed non-ST-elevation acute

coronary syndromes or acute heart failure. Partnering with Alere-San Diego Discovery, this project involves collaboration with Edmonton Regional Hospitals, Edmonton Emergency Medical Services and involves pre-hospital point of care biomarkers including Troponin and BNP. The project aims to enroll approximately 1800 subjects over the next 18-24 months. For further information please contact Courtney Bryden at 1-800-707-9098 (option 2) or email at courtney.bryden@ualberta.ca.

PROACT Providing Rapid Out of Hospital Acute Cardiovascu‐ lar Treatment An Edmonton‐region local initiative sponsored by the University Hospital Foundation and the Mazankowski Heart Institute

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The Canadian Cardiac Chronicle

How to Address Common Health Canada Inspection Findings Have you received your complimentary copy of Important Reference Documents on Conducting Clinical Research in Canada?

As many of you are aware, Health Canada is actively inspecting current clinical trials across Canada. The inspectors want to ensure that site personnel are aware of the Health Canada Division 5 regulations and are in compliance.

5. The following are some of the common findings that you can avoid and/or correct: 6. 1. 2.

All investigators and study coordinators should review and understand the information contained within this guide. Contact CVC for additional copies. Available in French and English.

Comment aborder les erreurs les plus communes identifiées lors des Inspections de Santé Canada Comme beaucoup d'entre vous le savent, Santé Canada inspecte activement les essais cliniques en cours partout au Canada. Les inspecteurs veulent s'assurer que les sites connaissent la règlementation de Santé Canada, Division 5 et sont en conformité.

6. Les éléments suivants sont quelques-unes des constatations communes que vous pouvez éviter et / ou corriger : 1.

Do you have Division 5 training and can you provide documentation that all site staff are trained? Does your site have Standard Operating Procedures (SOPs) and can you provide training records for all site staff? At minimum, you should have SOPs on the consent process, serious adverse event / adverse event capture and assessment; study drug procedures; and archiving of study records. Is the investigator involved in study subjects’ care during visits and has s/he

documented this? Is the administration of informed consent done in a timely manner and does documentation of the consent process exist? Do you have protocol training records (including any amendments) for all study staff involved? Does the investigator assess SAE/AEs for causality/relationship to study drug? This must be documented including signing and dating the assessment in a timely manner. Has the investigator reviewed and documented his/her assessment of central and/or local labs and any electrocardiograms? Is the equipment used for the study such as centrifuge, thermometer, scale or blood pressure cuff, etc. calibrated and can you provide calibration certificates? Are study files organized and all regulatory documents filed?

Visit the CVC website at www.vigour. ualberta.ca

3. 4.

Avez-vous complété la formation Division 5 et pouvez vous fournir la documentation que tous les membres de l’équipe à votre site ont été formés? Est-ce que votre site a des modes opératoires normalisés (MON) et pouvez vous fournir des dossiers de formation pour tout le personnel du site? Au minimum, vous devriez avoir des modes opératoires normalisés (MON) pour les consentements, les événements indésirables graves / collecte des événements indésirables et évaluation ; la procédure relié au médicament à l'étude et l'archivage des dossiers d'étude. Est-ce que l’investigateur est impliqué dans les soins du sujet d'étude lors des visites et est-ce documenté? Est-ce que l'administration du consentement éclairé est faite de manière

appropriée et est-ce que le processus de consentement est documenté? Avez-vous des dossiers de formation du protocole (y compris les amendements) pour tout le personnel impliqué dans l’étude? Est-ce que l'investigateur évalue les SAE / AE pour la causalité / relation au médicament étudié et est-ce documenté, y compris une signature et une date d’évaluation dans un délai approprié? Est-ce que l’investigateur a révisé et documenté son évaluation des laboratoires centraux / locaux et électrocardiogrammes? Est-ce le matériel que vous utilisez pour l'étude tels que centrifugeuses, thermomètres, balances ou brassards de pression sont calibrés et pouvez-vous fournir des certificats de calibration? Est-ce que les dossiers d'étude sont organisés et tous les documents réglementaires classés?

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Volume 15, No. 2

Preparing for a Monitoring Visit Are you always rushed to prepare for a monitoring visit? This process can be streamlined for both you and the monitor if you have completed the following requirements:

• Ensure all subject data is entered in the

eCRF is up to date and that source documentation exists to support entry.

• Ensure all source documents are available

for review during the visit. These documents can be source created by the study coordinator, study physician notes/ clinic chart, and hospital medical record. If

the hospital medical record is not available then a certified copy is acceptable.

• Ensure all subject consents are available for review including documentation of the consent process.

• Ensure all study drug logs are up to date

and that all study drug kits/bottles/pills are available for the monitor to count.

• Ensure all regulatory documents are filed in the appropriate section of the regulatory binder.

Beyond 2000 Launches New Website

CVC Presentations and Publications Since Last Issue Articles Mehta RH Starr AZ, Lopes RD, Piccini JP, Patel MR, Pieper KS, Armstrong PW, Granger CB. Relationship of sustained ventricular tachyarrhythmias to outcomes in patients undergoing primary PCI with varying underlying baseline risk. Am Heart J 2011; 161:782-9. Zalewski J, Bogaerts K, Desmet W, Sinnaeve P, Berger P, Grines C, Danays T, Armstrong P, Van de Werf F. Intraluminal thrombus in facilitated versus primary percutaneous coronary intervention: An angiographic substudy of the ASSENT-4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) Trial. J Am Coll Cardiol. 2011;57:1867-1873. With accompanying editorial by Applegate RJ. Optimal therapy for ST-segment elevation myocardial infarction: The role of residual thrombus. J Am Coll Cardiol. 2011;57:1874-1876. O’Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJV, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalán R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Méndez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Wilson WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of Nesiritide in Patients with Acute Decompensated Heart Failure. N Engl J Med 2011;365:32-43 (accompanied by an editorial)

Tricoci P, Newby LK, Hasselblad V, Kong DF, Giugliano RP, White HD, Théroux P, Stone GW, Moliterno DJ, Van de Werf F, Armstrong PW, Prabhakaran D, Rasoul S, Bolognese L, Durand E, Braunwald E, Califf RM, Harrington RA. Upstream Use of Small-Molecule Glycoprotein IIb/IIIa Inhibitors in Patients With Non–ST-Segment Elevation Acute Coronary Syndromes: A Systematic Overview of Randomized Clinical Trials. Circ Cardiovasc Qual Outcomes. 2011;4:448458. Armstrong PW, Westerhout CM, Van de Werf F, Califf RM, Welsh RC, Wilcox RG, Bakal JA. Refining clinical trial composite outcomes: An application to the ASSENT-3 trial. Am Heart J 2011; 161:848-54. Tymchak W, Armstrong PW, Westerhout CM, Sookram S, Brass N, Fu Y, Welsh RC. Mode of hospital presentation in non ST elevation myocardial infarction patients: Implications for strategic management. Am Heart J 2011;162:43643. Armstrong PW, Boden WE. Reperfusion Paradox in ST-Segment Elevaion Myocardial Infarction. Ann Intern Med 2011; 155:389-391. Lopes RD, Siha H, Fu Y, Mehta RH, Patel MR, Armstrong PW, Granger CB. Diagnosing Acute Myocardial Infarction in Patients With Left Bundle Branch Block Am J Cardiol 2011; 108(6):782-8. Bakal JA, Kaul P, Welsh RC, Johnstone D, Armstrong PW. Determining the cost economic “Tipping Point” for the addition of a regional percutaneous coronary intervention facility. Can J Cardiol 2011; 27(5): 567-72. ...continued

www.beyond2000.org now contains slide presentations from the sessions held on October 23, 2011, as well as selected video conversations with the Beyond 2000 XVII faculty about key topics in cardiovascu‐ lar medicine. Please explore this useful new knowledge translation resource.

Page 8 CANADIAN VIGOUR CENTRE

Canadian VIGOUR Centre Presentations and Publications Since Last Issue Address for Inquiries or Submission of Articles of Interest: 2-51 Medical Sciences Building University of Alberta Edmonton, AB T6G 2H7 Canada Phone: 1-800-707-9098 (Option 2) 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.

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

Articles (continued) French JK, Armstrong PW, Cohen E, Kleiman NS, O’Connor CM, Hellkamp AS, Stebbins A, Holmes DR, Hochman JS, Granger CB, Mahaffey KW. for APEX-AMI Investigators. Cardiogenic shock and heart failure post-percutaneous coronary intervention in ST elevation myocardial infarction observations from APEX-AMI. Am Heart J. 162(1); 89-97. Lopes RD, Becker RC, Alexander JH, Armstrong PW, Califf RM, Chan MY, Crowther M, Granger CB, Harrington RA, Hylek EM, James SK, Jolicoeur EM, Mahaffey KW, Newby LK, Peterson ED, Pieper KS, Van de Werf F, Wallentin L, White HD, Carvalho AC, Giraldez RR, Guimaraes HP, Nader HB, Kalil RAK, Mizzachi JMA, Lopes AC, Garcia DA. Highlights from the III international symposium of thrombosis and anticoagulation (ISTA), October 14-16, 2010, Sao Paulo, Brazil. J Thromb Thrombolysis 2011; 32(2):242-66. Abstracts Toleva O, Westerhout CM, Senaratne M, Bode C, Lindroos M, Ardissino D, Sulimov VA, Montalescot G, Newby LK, Giugliano RP, Van de Werf F, Armstrong PW. Association of hub and spoke practice patterns with coronary intervention and outcomes in non ST elevation acute coronary syndromes (NSTE ACS): Insights from the Early Glycoprotein IIb/IIIa Inhibition in NSTE ACS (EARLY-ACS) Trial. J Am Coll Cardiol 2011;57(Suppl A):E1101. Ezekowitz JA, Hernandez AF, O’Connor CM, Starling RC, Proulx G, Weiss MH, Bakal JA, Califf RC, Armstrong PW. Contributions of peak expiratory flow to assessment of acute decompensated heart failure: Insights from ASCEND-HF. Eur Heart J 2011; 32 suppl 1; 964. Leonardi S, Thomas L, Koehler ML, Tricoci P, Lopes RD, White HD, Armstrong PW, Newby LK, Mahaffey KW. What threshold should be used to define percutaneous coronary intervention-related myocardial infarction? An approach based on clinical relevance from EARLY ACS and SYNERGY. J Am Coll Cardiol 2011;57(Suppl A):E1239. Toma M, McAlister FA, Coglianese EE, Vidi V, Vasaiwala S, Bakal JA, Armstrong PW, Ezekowitz JA. Effect of testosterone supplementation on exercise capacity in heart failure patients: A systematic review and meta-analysis. J Am Coll Cardiol 2011;57(Suppl A):E329. De Ferrari GM, Van de Werf F, Armstrong P, Bode C, Lewis BS, Tricoci P, Guo J, Contant C,

Newby LK, Giugliano RP. Contrast induced nephropathy predicts later mortality among patients with non-ST-segment elevation acute coronary syndrome undergoing PCI: A sub-analysis from the EARLY ACS study. Eur Heart J 2011; 32 suppl 1; 657. Mehta RH, Kaul P, Lopes RD, Patel MR, Pieper KS, Armstrong PW, Granger CB. Variations in practice and outcomes in patients undergoing primary percutaneous coronary intervention in the United States and Canada: Insights from the APEX-AMI trial. Eur Heart J 2011; 32 suppl 1; 872. Ezekowitz JA, Virani S, Leader R, White M, Zieroth S, Delgado D, Proulx G, Hu J, Hernandez AF, Westerhout CM, O’Connor C, Armstrong PW. Acute heart failure: Canadian perspectives from an RCT and a registry. Can J Cardiol 2011; 27(5 Supplement): S246. Ezekowitz JA, Lepage S, Virani S, Leader R, White M, Proulx G, Zieroth S, Delgado D, Armstrong PW. Acute heart failure: A comparison of preserved and reduced ejection fraction in the emergency department. Can J Cardiol 2011; 27(5 Supplement): S245-S246.

Acknowledgments to our Sponsors: Amylin Pharmaceuticals, Inc. Boehringer Ingelheim GlaxoSmithKline Inc. Hoffmann-La Roche Merck & Co.,Inc. Regado Biosciences Inc. Sanofi-Aventis

Canadian Cardiac Chronicle Editorial Board: PW Armstrong

Dianne Payeur

Monica Adam

Carla Price

Courtney Bryden

Tracy Temple

Valencia Galbraith Lyndsey Garritty Adria Kwan Halina Nawrocki