WNICER celebrates the RELEASE OF THE ATTACC TRIAL RESULTS
The Worldwide Network for Innovation in Clinical Education and Research (WNICER) congratulates the ATTACC Trial team on the release of interim results that show full-dose blood thinners decreased need for life support and improved outcomes in hospitalized COVID-19 patients. The WNICER Network played an integral role in this multinational clinical trial led by Drs. Ryan Zarychanski and Patrick Lawlor. We acknowledge the contributions of University Health Network’s Peter Munk Cardiac Centre, University of Chicago, Mayo Clinic, The Brazilian clinical network led by Dr. José Nicolau of University of São Paulo’s InCor Heart Institute, and The Mexican clinical network led by Dr. Jorge Escobedo of the National Autonomous University of Mexico. See press release below.
Full-dose blood thinners decreased need for life support and improved outcomes in hospitalized COVID-19 patients in international trial
January 22- Full dose anti-coagulation (blood thinner) treatments given to patients hospitalized for COVID-19 reduced the requirement of vital organ support in a large clinical trial conducted worldwide. With large numbers of COVID-19 patients requiring hospitalization, this treatment is expected to reduce the pressure in intensive care units around the world.
Three clinical trial platforms spanning five continents in over 300 hospitals, have been working together since May 2020 to urgently test whether there is a greater benefit of full doses of heparin (blood thinners) to treat adults hospitalized for non-critical COVID-19 illness compared to the lower dose typically administered to prevent blood clots in hospitalized patients.
Based on the interim results of more than 1300 moderately ill patients admitted to hospital, findings showed that full doses of blood thinners were not only safe, but superior to the doses normally given to prevent blood clots in hospitalized patients. Moderately ill patients are those not in ICU and who did not receive organ support such as mechanical ventilation at trial enrollment. The trial investigators are now working as fast as possible to make the full results of the study available so clinicians can make informed decisions about treating their COVID-19 patients.
These trial results reported today complement the group’s findings announced in December that routine use of full-dose anti-coagulation when started in the ICU in critically ill COVID-19 patients was not beneficial and appeared to be harmful.
“In a disease with a limited number of effective therapies, our results have the potential to define a new standard of care for moderately ill hospitalized COVID-19 patients around the world,” said Ryan Zarychanski, MD, M.Sc., associate professor, hematologist and critical care physician at the University of Manitoba and CancerCare Manitoba, Canada, and chair of the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC) platform and of the therapeutic anticoagulation domain of the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).
Early in the pandemic, physicians around the world observed increased rates of blood clots and inflammation among COVID-19 patients which affected multiple organs and led to complications such as lung failure, heart attack and stroke. Whether providing increased doses of blood thinners routinely administered to hospitalized patients would be safe and effective was unknown at that time.
“These results are very exciting and lead us to better understand the impact of applying the right therapies at the right time in the course of this challenging disease,” said Dr. Judith Hochman, chair of Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) platform, Harold Snyder Family Professor & Associate Director of Cardiology, Senior Associate Dean for Clinical Sciences and Co-Director, NYU-HHC Clinical and Translational Science Institute, NYU Grossman School of Medicine.
Knowing the effect of full dose blood thinners in hospitalized patients with non-critical disease was a key outstanding question that has now been answered. Most COVID-19 patients hospitalized are non-critical and this study will impact their care and outcomes. The multiplatform trial further paves the way for future collaborations on a global scale.
“These are the first multi-platform international clinical trials ever undertaken and given the rapid discovery of Heparin’s positive impact on patient outcomes during the middle of the deadly COVID-19 pandemic, I don’t think it will be the last time researchers, clinicians and patients join forces across continents to test potential treatments against any number of diseases,” said Patrick Lawler, MD, MPH cardiologist at the University of Toronto and Peter Munk Cardiac Centre at University Health Network, who was co-principal investigator of ATTACC and a member of the international trial steering committee for REMAP-CAP.
“Having cared for so many severely ill Covid-19 patients and witnessed the suffering involved for patients and their loved ones, it is profoundly gratifying that together we have discovered a treatment that can prevent patients from becoming severely ill and improve their recovery,” said critical care physician Ewan Goligher, MD, PhD, and co-chair of the therapeutic anticoagulation domain in REMAP-CAP, and assistant professor of medicine, University of Toronto and scientist, University Health Network.
Clinical trials, overseen by independent boards, routinely review data. The positive conclusions drawn from results to date at these trial sites have now led to enrollment being stopped. However, an adaptive approach in response to scientific data enables this study, like others, to conduct safe, rapid testing of additional agents and evolve accordingly.
The trials are supported by multiple international funding organizations including Canadian Institutes of Health Research (CAN), the LifeArc Foundation, the NIH National Heart, Lung & Blood Institute (US), National Institutes of Health Research (UK), National Health and Medical Research Council (AUS), Health Research Council of New Zealand, and the PREPARE and RECOVER consortia (EU).
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Contact: Ilana Simon
University of Manitoba
University Health Network -- Toronto General Hospital and Peter Munk Cardiac Centre
WNICER celebrates the publication of the TAILOR-PCI trial in JAMA
August 25, 2020
WNICER celebrates the publication of the TAILOR-PCI Randomized Clinical Trial results in the Journal of the American Medical Association (JAMA). The trial highlights the potential clinical impact of a personalized strategy to managing antiplatelet therapy post PCI.
We would like to congratulate and thank WNICER members Drs. Naveen L. Pereira, Michael E. Farkouh, Derek So, Verghese Mathew, Shaun G. Goodman, Mandeep Sidhu, Jean-Francois Tanguay, Yves Rosenberg and other colleagues for their tireless efforts towards advancing science.
Question: Does CYP2C19 genotype–guided prescription of oral P2Y12 inhibitor therapy after percutaneous coronary intervention (PCI) improve ischemic outcomes in patients with acute coronary syndromes and stable coronary artery disease?
Findings: In this randomized clinical trial that included 5302 patients undergoing PCI and included 1849 patients with CYP2C19 loss-of-function alleles in the primary analysis, genotype-guided selection of oral P2Y12 inhibitor therapy, compared with conventional therapy using clopidogrel, resulted in no significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, or severe recurrent ischemia at 12 months (4.0% vs 5.9%, respectively; hazard ratio, 0.66).
Meaning: Among patients with CYP2C19 loss-of-function alleles who underwent PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy, did not significantly reduce ischemic events based on the treatment effect that the study was powered to detect at 12 months.
Click here to read the full article.
Click here to read the editorial.
On December 14th, our partner The Cura Foundation hosted a webinar on Bridging the Gap Between Faith and Science. The panelists were Rev. Kevin FitzGerald, SJ, PhD, Aasim I. Padela, MD, MSc, Rabbi Edward Reichman, MD, and Tyler VanderWeele, PhD. The discussion was moderated by Mehmet C. Oz, MD. View the webinar below.
As a result of this discussion, Dr. Robin L. Smith and Dr. Mehmet Oz published an Op-Ed published on January 6, 2021 there they argued that public health officials need to engage with leaders of both science and faith-based organizations to fight the COVID-19 pandemic. Click here to read the Op-Ed.
Acute and Chronic Cardiovascular Complications of COVID-19 Webinar
On October 26 2020, The Worldwide Network for Innovation in Clinical Education and Research (WNICER) and The Cura Foundation hosted a webinar to discuss acute and chronic cardiovascular complications of COVID-19. The panelists were Michael E. Farkouh, MD (University of Toronto), Sascha Goonewardena, MD (University of Michigan Medical School), Peter Libby, MD (Harvard Medical School) and Robert S. Rosenson, MD (The Icahn School of Medicine at Mount Sinai). The discussion was moderated by Max Gomez, PhD, Senior Medical Correspondent, CBS2 New York.
View the webinar.
Long-Term Effects of COVID-19 Webinar
What are the long term effects of COVID-19? How will COVID-19 impact patients' health in the future? On October 5th, William Li, MD, President, Medical Director and CEO of The Angiogenesis Foundation and Andrew von Eschenbach, MD, Previous Commissioner of the U.S. Food and Drug Administration and Former Director of the U.S. National Cancer Institute had a fireside chat on the long-term effects of the novel coronavirus on the health and wellbeing of its survivors. The webinar was moderated by Max Gomez, PhD, Senior Medical Correspondent of CBS2 New York and was hosted by WNICER partners The Cura Foundation and The Angiogenesis Foundation.
View the webinar below.
DR. VERGHESE MATHEW'S WNICER APPOINTMENT
Mr. John Brooks, CEO of the Worldwide Network for Innovation in Clinical Education and Research (WNICER) is pleased to announce that Dr. Verghese Mathew will assume the role of Director of the Cardiovascular Investigator Program at the WNICER effective Monday, December 16, 2019.
Dr. Mathew is a Professor of Medicine at Loyola University Chicago Stritch School of Medicine. He has been a high volume academic interventional cardiologist for more than 2 decades. He was a consultant cardiologist at Mayo Clinic from 1997-2016, holding a number of leadership positions in the cardiac and vascular arenas, with joint appointments in the departments of medicine, cardiology, and radiology; he was recruited to Loyola University Medical Center in 2016 to lead the division of cardiology.
Dr. Mathew has done extensive work in the field of interventional cardiology including complex CAD, peripheral arterial interventions, and TAVR- with both basic and translational research programs. He has been an investigator in many trials that have evaluated and led to the approval of currently utilized technologies, such as coronary stents/drug eluting stents and transcatheter aortic valve replacement (TAVR); as well as phase II-IV pharmacologic studies focused on antiplatelet and anticoagulant drugs in the context of coronary interventions. He has published extensively in the field of interventional cardiology.
Dr. Mathew has a keen interest in integrated models of care, focusing on the appropriate application of advanced cardiovascular therapies to complex patient subsets. He continues to be an invited speaker at many national and international cardiovascular scientific conferences.
Dr. Mathew is board certified in interventional cardiology and cardiovascular diseases. He is a Fellow of the American College of Cardiology and a Fellow of the Society for Cardiovascular Angiography and Interventions.