the canadian cardiac chronicle - winter 2014

The Canadian Cardiac Chronicle

Volume 18, No. 4 Winter 2014

Canadian Clinical Trial Performance: Embarking on an ODYSSEY to further IMPROVE-IT

I recently returned from the cold and windy city of Chicago-- to the cold and windy city of Toronto--where I attended the 2014 American Heart Association Scientific Sessions. During my flight home, I read an article in the Wall Street Journal highlighting the long-awaited results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT). Nine years after this important global randomized clinical trial started, the preliminary findings from 18,144 post-acute coronary syndrome patients had finally been presented from the Late Breaking Clinical Trials podium and were now in the public domain.

The Journal headline described the addition of ezetimibe to simvastatin therapy as showing a “…modest benefit in reducing heart attacks…”. However, the subtitle of the article more ap-propriately captured the spirit of this enormous undertaking by physicians, study coordinators, and academic research organi-zations: “Trial Marks a Milestone in Battle to Fight Cardiovascu-lar Disease by Lowering Cholesterol”. Indeed, the IMPROVE-IT trial represents the first time that adding a non-statin lipid modifying agent to patients’ secondary prevention regimen not only resulted in even lower LDL cholesterol levels, but led to a significant reduction in subsequent cardiovascular events.

Canadian contribution to this trial was substantial--we were the 3rd highest enrolling country (of 39) in the world with 1,106 patients from 64 sites! The IMPROVE-IT trial, consistent with the vision of the Canadian VIGOUR Centre (CVC) “…to generate, translate and disseminate knowledge on novel…therapeutics strategies in cardiovascular medicine acquired through collaborative research to enhance the health of the citizens of…Canada, and the world” embodied our core values of quality, collaboration, integrity, and respect. Indeed, one measure of the outstanding Canadian effort was the fact that only 5 patients (<1%) were lost to follow-up at sites collaborat-ing with the CVC. This is a remarkably low rate in the context of a trial that identified >5,300 primary endpoints during almost 100,000 total patient-years of follow-up.

Of course, to get to the finish line, one has to first enroll the “right” patient from the start. Even after careful identification of potentially eligible patients, recruitment requires a discussion with the patient (and often their family member[s]) as part of the informed consent process, including the importance of maintaining study drug and regular follow-up assessments. As in most trials like IMPROVE-IT, participants are analyzed according to their allocated treatment (i.e., intention-to-treat) even if they temporarily or permanently discontinue study drug. The potential treatment effect may be diluted or even nullified if we aren’t able to keep our patients on the assigned study drug. This critical issue was brought to the forefront midway through the trial when negative publicity regarding ezetimibe required the IMPROVE-IT leadership to provide compelling arguments that the study needed to continue. We still didn’t have the answer to whether ezetimibe could improve clinical outcomes. Indeed, continued enrollment and adherence to study drug treatment in the trial was both ethical and vital. However, despite the global challenge of keeping patients on study drug, particularly in such a long-term trial with negative press, Canada’s rate of study drug continuation was above the trial average, representing yet another indication of the high quality of Canadian investigator and coordinator engagement in order to maintain high intensity patient participation.

In addition to demonstrating the safety and efficacy of ezetimibe, the IMPROVE-IT investigators were able to reaffirm the LDL hypothesis—that lowering LDL (even with a non-statin agent) prevented cardiovascular events. Furthermore, the axiom that “even lower is better” was confirmed: patients on statin therapy alone achieved mean LDL cholesterol levels

The CVC is proud to be a University of Alberta Centre

In This Issue:Letter - Shaun Goodman 1-2Trial Updates 2-6 Monitoring 7CVC News 7Publications 8

The Canadian Cardiac Chronicle - Volume 18

below the current Canadian Cardiovascular Society Guideline recommended target of <2 mmol/L while those receiving combination therapy achieved even lower levels at 1 year.

The abovementioned outstanding Canadian participation and performance, together with the unique findings of benefit in the IMPROVE-IT, are extremely encouraging to those of us engaged in the next lipid-modifying treatment frontier. Indeed, many of you are working hard to identify, enroll, and randomize post-ACS patients in the ODYSSEY Outcomes trial comparing the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab to placebo. This treatment (based in part upon the Canadian discovery of the role of PCSK9 in the recycling of LDL receptors), is added on top of maximally tolerated high-intensity statin therapy with or without concomitant use of ezetimibe. Findings from recently presented shorter-term phase III trials—including several from the AHA sessions in Chi-cago--have demonstrated both a robust LDL-lowering capacity (e.g., 36%-62%) and remarkable safety profile (indistinguish-able from placebo) of alirocumab. We are hopeful that we

can—similar to the Canadian performance in IMPROVE-IT—contribute to the global efforts to translate these types of benefits in randomized clinical outcome trials and ultimately into routine clinical practice for our patients.

But in case you had thoughts similar to mine as the holiday season approaches, alirocumab—a fully human monoclonal antibody—is currently only available as an injectable experimental treatment as part of a clinical investigational study and unfortunately cannot be added to the gravy you will pour on top of your festive turkey dinner! And of course, the addition of ezetimibe and statin to the meal definitely represents non-approved, off-label use so proceed with caution…

Best holiday wishes to you and yours,

Co-Director’s Letter Continued...

IMPROVE-IT

After a nine year journey the moment finally arrived on November 17, 2014 in Chicago as Dr. Christopher Cannon presented the IMPROVE IT results during the Late-Breaking Clinical Trials session. We were pleased to see some of our in-vestigators and coordinators at this meeting and glad they were able to join us for the Investigator Meeting Sunday evening at the AHA.

As you know, the main goal of the study was to discover if lowering LDL-C with the non-statin agent ezetimibe reduced cardiac events. “Is (Even) Lower (Even) Better?”

And the results were POSITIVE! IMPROVE IT was the first trial to demonstrate incremental clinical benefit when adding a non-statin agent (ezetimibe) to statin therapy. The study showed that lowering LDL-C with non-statin ezetimibe reduced cardiovascular events. Furthermore, it confirmed the safety profile of ezetimibe. There were no statistically significant differences with regards to safety between the two groups (simvastatin vs EZ/simva). A complete publication of the trial

results are expected in the coming months and will be distributed to our participating sites.

There were more than 18,000 patients enrolled in this trial at over 1100 sites in 39 countries. We’d like to thank all of our in-vestigators and study coordinators across Canada who worked hard to recruit patients into the study. Moreover, we’d like to recognize the outstanding efforts in the area of patient retention that was demonstrated by our sites throughout the course of this lengthy trial. The quality of our Canadian data is a testament to your commitment, patience and perseverance! We are proud of our Canadian contribution to this important trial! Congratulations on a job well done!!

We still have a few things to clean up in the coming months as we prepare to close and archive this study. While we anticipate closing all sites over the next month, please do not close the study with your REB until you have been officially notified by the Project Lead to do so.

For further information, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800-707-9098, ext. 3 or by email at [email protected].

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

Shaun Goodman


In October, training was provided for the new EXSCEL Screen Failure system. At least one staff member from your site requires access to this system. If you don’t have access yet please contact your Project Lead for assistance. Please remember that only patients that have signed a consent form, but are not randomized into the study, can be entered in the system. The deadline to enter all retrospective screen failures is January 5, 2015 so please do not delay in getting access and entering your screen failures.

Once again we would like to congratulate you on your work to keep patients in the trial. Canada still has zero patients that are lost to follow-up and zero patients that have withdrawn consent. We know that Canadian’s great retention rates are due to your efforts and we thank you for them.

For further information about this trial, please contact Clinical Trial Project Lead, Courtney Gubbels at 1-800-707-9098, ext. 1 or by email at [email protected] or Diane Camara at 1-800-725-6585 ext:287 or by email at [email protected].

Sponsored by Bristol-Myers Squibb (transition to AstraZeneca currently in progress), this trial is a pragmatic, long term, placebo- controlled, double-blinded trial which seeks to characterize the effects of exenati-de 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.

Exenatide Study ofCardiovascular Event Lowering

A big thank you to all the Canadian EXSCEL sites who continue to screen and enroll patients and keep their study files up to date! As of Nov 21, 2014 there are 12,365 patients enrolled globally. Canada has been enrolling well over the last 3 months, with an average of 11 patients per month, and currently has a total of 476 patients enrolled. We greatly appreciate your dedication to this trial!

A special welcome to the following four new sites who were recently activated in the EXSCEL trial.

• PI Robin Conway – SC Emily Knapp• PI Giuseppe Mazza – SC Marie-Claude Arsenault• PI Ronald Hatheway – SC Coleen Kelly• PI Jacek Misterski – SC Marianne Roth

We are pleased to announce that all four new sites have enrolled into the trial.

TECOS continues to be in full gear the last several months as we have been working hard to clean up the data and prepare for database lock. We are appreciative to our Canadian sites who have come on strong in the last several months and were able to successfully find a vital status on all patients including our withdrawn consent patients. We were also pleased that our only lost to follow up patient in Canada was located recently which dropped that number to zero and put us in an excellent position moving into database lock. While we are still working to answer queries that come up weekly our overall data in Canada looks great. All of our sites should take a bow for this tremendous effort.

Our monitors have also kept the sites busy as they work to complete final visits. As a reminder to all of our sites who have had a final visit, this does not mean your site is closed, only that you have had a final monitoring visit. Your closeout will officially be completed once the database has been locked. Please ensure your site remains open with ethics and if your annual renewals are coming due that you submit for renewal well in advance. As you prepare for these final visits please ensure your regulatory binder is up to date, that all safety reports have been submitted, your drug accountability is complete and any open data queries are closed. As a reminder a copy of all ethics

TECOS

EXSCEL

submission and acknowledgements of safety reports and line listings should be emailed to us for filing. We are currently in the process of reconciling all documents that are missing and appreciate your follow up to close off these items with Kalli as quickly as possible.

As we move into December we want to wish everyone a relaxing, peaceful and well deserved holiday. We look forward to sharing the results of this exciting trial with you in the New Year.

If you have any questions please don’t hesitate to contact Tracy Temple, Assistant Director – Clinical Trials and acting Project Lead at 1-800-707-9098 Option 5/[email protected] or Kalli Belseck, Regulatory Specialist at 1-800-707-9098/[email protected].

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.



Providing Rapid Out of Hospital AcuteCardiovascular 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.


PROACT

As we approach the end of 2014, the ODYSSEY Outcomes trial is approaching a great milestone – we have now randomized nearly 9,000 patients globally - one half of our total recruitment goal! Canada has been very active in contributing to the on-going success in recruitment, as our sites have set several new records, both at a Country and site level. October 2014 saw us set a new record, with over 30 patients screened! We also had sites set new, impressive records, for both screening and randomization:

• Dr. James Stone – S.C. Meagan Heard – 8 patients screened in 1 month

• Dr. Gilbert Gosselin – S.C. Margaux David – 5 patients randomized in 1 month

Canada currently has over 130 patients randomized across 35 active sites. We truly appreciate all of your hard work and the focused efforts that you have put forth on behalf of the ODYSSEY Outcomes trial. We would like to congratulate our current top randomizing sites (data as of 21Nov2014):

• PI Manahora Senaratne – SC Himani Ferdinandis – Edmonton, AB

• PI Jan Kornder – SC Lynn Breakwell – Surrey, BC• PI Gilbert Gosselin – SC Margaux David – Terrebonne, QC• PI James Stone – SC Meagan Heard – Calgary, AB• PI Simon Kouz – SC Madeleine Roy – St-Charles-Borromée,

QC

It is very exciting to see more and more of our sites reaching the double digits for number of patients randomized – your hard work is definitely paying off!

In addition to the encouraging data presented at the ESC this past August, detailed results were presented as part of a special session on the ODYSSEY program at the American Heart

Association Scientific Sessions in Chicago, IL. All six trials, ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH met their primary efficacy endpoint of a greater reduction in LDL-C at 24 weeks, versus either active comparator or placebo, which included standard-of-care therapy – very exciting news!

We also hope that you have had a chance to listen to the video communications that we have shared with you, which further discuss these exciting results and highlight why they are relevant and important for the ODYSSEY Outcome trial. If you have missed out on the updates or videos, or if you have any questions, please contact the Project Lead.

As we head into the holiday season, please remember to notify Amanda of any site closures or Study Coordinator vacations. This will help us ensure that no shipments go out to your site while you are unable to receive them. We look forward to meeting with you all at our next Canadian Update WebEx! As always, please let us know if there are any specific topics you would like us to address.

We are still recruiting a few final sites for this study. Should you be interested in hearing more about ODYSSEY Outcomes or have questions regarding the trial, please contact Clinical Trials Project Lead Amanda Carapellucci at 1-800-707-9098 (ext. 2) or by email at [email protected] or Paula Priest (ext. 9) or [email protected].

ODYSSEY OUTCOMES

PROACT

Sponsored by Sanofi-aventis Recherche & Développement this is a randomized, double-blind, placebo-controlled, paral-lel-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.


We are in the home stretch on the PROACT trial with 544 patients recruited as of November 24, 2014. Thanks to the ongoing dedication of the Edmonton Medical Services paramedics the PROACT study should complete enrollment by the end of this year.

We will be looking to clean the data moving into the new year and hope to unravel the results in the spring. Again we would like to thank all of the staff at Edmonton Medical Services for their part in advancing the care of patients in the pre-hospital arena.

For further information please contact Paula Priest at 1-800-707-9098 (ext 9) or email at [email protected].


As of November 13, 2014 we have recruited 427 subjects in the overall trial with 47 of those from Canada. All sites are working hard to at least meet, if not exceed, the NIH expectations of 28 subjects enrolled per month in the trial. We have our eye on Canada enrolling the 450th subject!

Congratulations to all 6 Canadian sites for enrolling at least 1 subject each since September –we look forward to seeing increased enrollment over the next few months. Keep an eye on your mail – DCRI will be distributing GUIDE-IT “swag” as a thank you for your hard work and contributions to the trial.

As a reminder it is critical that patients randomized to the bio-marker-guided arm have therapy adjustments made if NT-proBNP is above the target level of 1000 pg/mL. If you have any questions related to this please don’t hesitate to contact Melisa.

Per NIH regulatory requirements, please ensure that Conflict of Interest forms are completed annually for all Investigators at your site. This is a requirement by the NIH for the duration of the GUIDE-IT trial. COI should be renewed prior to expiry of the previously completed disclosure; Melisa will work with your

site to ensure these are renewed in a timely manner.

Congratulations to PI - Dr. Grant and SC- Kim Ronak at Foothills Medical Centre on randomizing Canada’s first patient in the ECHO sub-study in October! The same site enrolled Canada’s first subject in the main GUIDE-IT trial in October, 2013 so this is a fitting accomplishment. Well done! We look forward to activating our other 2 participating sites, Dr. Ezekowitz / Quentin Kushnerik and Dr. Virani / Naomi Uchida on the ECHO sub-study as well!

For further information, please contact Clinical Trial Project Lead Melisa Spaling at [email protected] or direct: 1-780-492-8476.

GUIDE-IT

AEGIS-IThe Safety Lead-In phase of the AEGIS-I trial is now complete. Enrollment in the main study phase is expected to start early in the new year once the DSMB have met and reviewed the data from the Safety Lead in.

We currently have 9 sites across Canada that will be participat-ing in this trial and are presently working towards getting ethics approval and contracts finalized at their site. Congratulations to Dr. Fam and Dr. Cheung’s sites who have already submitted to their ethics committees. Great job!

The North American Investigator Meeting is now confirmed for late January in Miami, Florida. We look forward to a great turnout from our Canadian sites. This will be a good opportunity to review the protocol and study procedures with representa-tives from all participating Canadian sites and I’m sure the warmer weather will also be welcome. Stay tuned for additional meeting information coming soon!

In order to meet our goal of activating the first Canadian sites in early February following the Investigator meeting, we will be energetically working with each site to obtain ethics approval, a finalized contract and regulatory document submission over the next couple months. If you need any assistance with site activation requirements please let us know. We are always happy to help in any way we can.

For further information about this trial, please contact Clinical Trial Project Lead, Courtney Gubbels at 1-800-707-9098, ext. 1 or by email at [email protected].

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



Sponsored by CSL Behring LLC, this study is a Phase 2b, multicenter, ran-domized,p lacebo-contro l led , dose-ranging study to investigate the safety and tolerability of multiple dose administration of CSL112 in subjects with acute myocardial infarction.

SODIUM-HF

BLAST-AHF

The BLAST-AHF study is a Phase 2b trial that will enroll up to 500 adult subjects, across 80 sites globally, to evaluate the safety and efficacy of TRV027 on symptoms of acute decom-pensated heart failure when administered in addition to standard of care.

We are working with three participating sites in Canada including the University of Alberta Hospital (Edmonton), Ottawa Heart Institute, and St. Paul’s Hospital (Vancouver).

Congratulations to Dr. Justin Ezekowitz and Quentin Kushnerik at University of Alberta Hospital, on your recent activation. We

look forward to seeing your site’s (and Canada’s) first subject enrolled!

While we prepare for the interim analysis, enrollment will continue to be temporarily paused at all sites. Please be assured that CVC will provide all participating sites with updates and results from the interim analysis when this information is available from the sponsor. We anticipate this time will allow our remaining sites to be fully prepared for activation post analyses and look forward to having Canada contribute very soon to the recruitment in this study.

If you are interested in further information about BLAST-AHF, please contact Clinical Trial Project Lead Melisa Spaling at 780-492-8476 or via email at [email protected]

Sponsored by Trevena Inc., BLAST-AHF is A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure.


There have been some exciting developments in the SODIUM-HF trial over the past few months! We currently have 10 active sites in Canada and 32 subjects randomized (current as of 13-Nov-2014). During October, a total of 8 subjects were randomized which is a new trial best – we are confident this record will be shattered in the winter months!

Additional international sites have expressed interest in partic-ipating in the trial. We are in the process of on-boarding several sites in Mexico, Chile, and Argentina and look forward to this exciting collaboration.

Congratulations to a number of sites on randomizing your first subject:

• Dr. Hanninen, Lindsay Thompson and Janice Throndson (St. Mary’s Hospital, Camrose, AB)

• Dr. Toma and Sinead Feeney (St. Paul’s Hospital, Vancouver, BC)

• Dr. Virani, Naomi Uchida, and Elan Wang (Vancouver General Hospital)

Congratulations to Dr. Ross, Lisa Garrard and Margaret Brum on your continuing reign as the trial enrollment leader with a total of 15 subjects randomized!

Welcome Winnie Christopher and Yobiga Thevakumaran, working with Dr. Gupta at Brampton Research Associates

The monthly Dietitian (and Study Coordinator) Working Group Calls have been off to a great start. Thank you to all sites who have joined the last 2 calls – these are a great opportunity to ask questions and hear other sites’ / dietitians’ experiences with the trial. If you have not had a chance to join, the next call will be Thursday, December 4 at 1 PM Eastern Time!

Reminders:

• 3-days food records should be submitted within 3 business day of the study visit to [email protected]

• Patients should be randomized on the day of their baseline visit. This eliminates a number of potential problems that occur if a patient is randomized but does not show up for their baseline visit.

If you are interested in further information about SODIUM-HF, please contact Clinical Trial Project Lead Melisa Spaling at 780-492-8476 or via email at [email protected].


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.


The monitoring team would like to thank each site for accom-modating us during the recent months while we performed final visits for the IMPROVE IT and TECOS studies as well as study drug returns for EXSCEL. We always appreciate the opportunity to interact with you on site and thought we would share a few tips to help you continue preparing for successful and productive monitoring visits in the future:

• Ensure that all central lab reports are not only signed & dated by the investigator but also that out of range values are reviewed and documented as clinically significant(CS) or not clinically significant (NCS).

• Review your previous monitoring visit follow up letter to ensure all requested items have been completed or closed.

• Ensure your consent process is documented for each consent that is administered.

• Ensure there is access to the original medical record for source data verification.

• Ensure that study drug logs are up to date and all study drug can be accounted for.

If you have any questions related to monitoring please don’t hesitate to contact Halina Nawrocki, Lead CRA at [email protected] or Tracy Temple, Assistant Director – Clinical Trials at [email protected].

Monitoring

CVC NewsShaffin Kherani joined the CVC as the new Assistant Director, Operations in October 2014. He comes to CVC from the Government of Alberta where he spent time with the Ministries of Treasury Board and Finance, Advanced Education and Infrastructure. Most recently was involved with the Strategic Partnerships Office of Alberta Infrastructure, where he was responsible for seeking out cre-ative partnerships including public-private partnerships through which infrastructure projects could more effectively be delivered.

Prior to joining the government, Shaffin worked in different private sector industries including commercial banking, biotechnology and IT.

Shaffin completed all of his post-secondary education at the University of Alberta. In addi-tion to a science degree, he holds an MBA and also a Master’s degree in Ag Economics.

Outside of work, Shaffin enjoys spending time with friends and family, staying active, trying new restaurants and despite how painful it has been lately, he is an Edmonton Oilers fan.

December 24 2014 to January 1, 2015Should 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.

CVC Holiday Closure


Publications

Address for Inquiries: 2-132 Li Ka Shing Centre for Health Research Innovation University of Alberta, Edmonton, AB, Canada, T6G 2E1Phone: 1-800-707-9098, Fax: (780) 492-0613www.vigour.ualberta.ca

This newsletter is published periodically as a service to Canadian investiga-tional 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

Canadian Cardiac Chronicle Editorial Board:

Alere Inc.AstraZenecaBristol-Myers SquibbCSL Behring LLCMerck & Co., Inc.

Paul W. ArmstrongKalli BelseckAmanda CarapellucciJustin EzekowitzShaun Goodman

Courtney GubbelsHalina NawrockiJodi ParrottaPaula Preist

Ellen PyearYvonne RegnierMelisa SpalingTracy Temple

Publication Information

Roche Diagnostics Operations Inc. Sanofi-aventis Recherche & Développement Trevena Inc.Canadian Institute of Health ResearchMazankowski Alberta Heart InstituteUniversity Hospital Foundation

CVC gratefully acknowledges our sponsors and the funding support provided by:

Bakal JA, McAlister FA, Liu W, Ezekowitz JA. Heart Failure Re-Admission: Measuring the Ever Shortening Gap between Repeat Heart Failure Hospitalizations. PLoS One. 2014;9:e106494. http:/www.ncbi.nlm.nih.gov/pubmed/25211034

Kaila KS, Norris CM, Graham MM, Ali I, Bainey KR. Long-term survival with re-vascularization in South Asians admitted with an acute coronary syndrome (from the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease Registry). Am J Cardiol. 2014;114:395-400. http://www.ncbi.nlm.nih.gov/pubmed/24927971

Ezekowitz JA. Time to Energize Coenzyme Q10 for Patients with Heart Failure? JACC Heart Fail. 2014;2:650-652. http://heartfailure.onlinejacc.org/article.as-px?articleID=1911596

Hammal F, Ezekowitz JA, Norris CM, Wild TC, Finegan B. Smoking status and survival: impact on mortality of continuing to smoke one year after the

angiographic diagnosis of coronary artery disease, a prospective cohort study. BMC Cardiovasc Disord. 2014;14:133. http://www.ncbi.nlm.nih.gov/pubmed/25274407

Colin-Ramirez E, Castillo-Martinez L, Orea-Tejeda A, Zheng Y, Westerhout CM, Ezekowitz JA. Dietary fatty acids intake and mortality in patients with heart failure. Nutrition. 2014;30:1366-1371. http://www.ncbi.nlm.nih.gov/pubmed/25280414

Patel PA, Heizer G, O’Connor CM, Schulte PJ, Dickstein K, Ezekowitz JA, Armstrong PW, Hasselblad V, Mills RM, McMurray JJ, Starling RC, Tang WH, Califf RM, Hernandez AF. Hypotension During Hospitalization for Acute Heart Failure Is Independently Associated With 30-Day Mortality: Findings from ASCEND-HF. Circ Heart Fail. 2014;7:918-925. http://www.ncbi.nlm.nih.gov/pubmed/25281655

Felker GM, Ahmad T, Anstrom KJ, Adams KF, Cooper LS, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL, Leifer ES, Mark DB, Desvigne-Nickens P, Paynter G, Piña IL, Whellan DJ, O’Connor CM. Rationale and Design of the GUIDE-IT Study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure. JACC Heart Fail. 2014:2;457-465. http://www.ncbi.nlm.nih.gov/pubmed/25194287

Park DW, Clare RM, Schulte PJ, Pieper KS, Shaw LK, Califf RM, Ohman EM, Van de Werf F, Hirji S, Harrington RA, Armstrong PW, Granger CB, Jeong MH, Patel MR. Extent, Location, and Clinical Significance of Non-Infarct-Related Coronary Artery Disease Among Patients With ST-Elevation Myocardial Infarction. JAMA. 2014;312:2019-2027. http://www.ncbi.nlm.nih.gov/pubmed/25399277

Bagai A, Schulte PJ, Granger CB, Mahaffey KW, Christenson RH, Bell G, Lopes RD, Green CL, Lincoff AM, Armstrong PW, Roe MT. Prognostic implications of creatine kinase-MB measurements in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention. Am Heart J. 2014;168:503-511.e2. http://www.ncbi.nlm.nih.gov/pubmed /25262260

Jones WS, Tricoci P, Huang Z, Moliterno DJ, Harrington RA, Sinnaeve PR, Strony J, Van de Werf F, White HD, Held C, Armstrong PW, Aylward PE, Chen E, Patel MR, Mahaffey KW. Vorapaxar in patients with peripheral artery disease and acute coronary syndrome: Insights from Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER). Am Heart J. 2014;168:588-596. http://www.ncbi.nlm.nih.gov/pubmed/25262270


http://www.ncbi.nlm.nih.gov/pubmed/25211034





http://heartfailure.onlinejacc.org/article.aspx?articleID=1911596

http://heartfailure.onlinejacc.org/article.aspx?articleID=1911596



http://www.ncbi.nlm.nih.gov/pubmed/%0D25280414%0D

http://www.ncbi.nlm.nih.gov/pubmed/%0D25280414%0D

http://www.ncbi.nlm.nih.gov/pubmed/25281655%0D








the canadian cardiac chronicle - winter 2014

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