“The significance and potential far-reaching impact of a clinical trial of this scope will push the boundaries about the benefits that personalized medicine for patients who undergo a coronary stent procedure can provide,” says Dr. Barry Rubin, Medical Director, Peter Munk Cardiac Centre, University Health Network (UHN). “The validation provided by the NHLBI through this important grant is further evidence of our leadership role in large-scale cardiovascular studies requiring international clinical trials expertise and a multi-disciplinary team approach,” he says. “This is the largest trial to evaluate a personalized molecular medicine approach to patients with heart disease that has even been carried out.”
When it began in 2013, TAILOR-PCI included study teams at 15 hospitals from Canada, the U.S, and South Korea, with a goal of enrolling 5,270 patients. Now, some 29 medical centres are participating, with more expected. Launched by Mayo Clinic Center for Individualized Medicine and the Department of Cardiovascular Diseases at Mayo Clinic, in collaboration with the Peter Munk Cardiac Centre, the Applied Health Research Centre at the University of Toronto, and Spartan Bioscience, Ottawa, the study involves the randomized comparison of Plavix (clopidogrel bisulfate) and Brilinta (ticagrelor), based on genetic testing that identifies resistance to ticagrelor in patients undergoing coronary balloon angioplasty.
“This is a multinational collaboration designed to inform clinical practice, in its truest sense,” says Dr. Michael Farkouh, cardiologist, Chair, Peter Munk Centre of Excellence in Multinational Clinical Trials and one of two principal investigators of TAILOR-PCl. The other principal investigator is Dr. Naveen Pereira, cardiologist at the Mayo Clinic. “We are delighted to partner with the Mayo Clinic in this effort,” says Dr. Farkouh.
The study is examining whether prescribing heart medication based on a patient’s CYP2C19 genotype will help prevent heart attack, stroke, unstable angina, and cardiovascular death in patients who undergo percutaneous coronary intervention (PCI). A PCI, commonly known as an angioplasty, is a non-surgical procedure that opens up narrowed or blocked blood vessels in the heart.
“NHLBI is happy to support this important study, which we hope will contribute to the evidence needed to start delivering precision medicine in clinical settings,” says Dr. Yves Rosenberg, NHLBI program officer for the study, and chief of the Atherothrombosis and Coronary Artery Disease Branch. “This trial could have global impact by potentially changing treatment recommendations for millions of individuals with coronary artery disease needing antiplatelet treatment after a percutaneous coronary intervention.”
Anti-platelet medication has been shown to reduce the risk of heart attack, unstable angina, stroke and cardiovascular death after stent placement by reducing the possibility of blood clots around the site of the surgical incision. The current standard of care after angioplasty is to prescribe clopidogrel for one year. “Today, we do this regardless of a person’s individual genotype, even though we have known for several years that variation in the CYP2C19 gene may diminish the benefit from the drug,” says Dr. Pereira. “What we don’t know — and why there is such confusion in the cardiovascular community — is whether these genetic differences affect long-term clinical outcomes.”
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ABOUT THE PETER MUNK CARDIAC CENTRE
The Peter Munk Cardiac Centre is the premier cardiac centre in Canada. Since it opened in 1997, the Centre has saved and improved the lives of cardiac and vascular patients from around the world. Each year, approximately 55,000 patients receive innovative and compassionate care from multidisciplinary teams in the Peter Munk Cardiac Centre, and the Centre trains more cardiologists, cardiovascular surgeons and vascular surgeons than any other hospital in Canada. The Centre is based at the Toronto General Hospital and the Toronto Western Hospital - members of University Health Network. www.petermunkcardiaccentre.ca
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