Brigham and Women's Hospital to Lead Phase III Clinical Trial for New Class of Medication for Patients with Atherosclerosis
New antiplatelet medication to potentially reduce risk for heart attack and stroke
Boston, MA - Brigham and Women's Hospital (BWH) announced today that it will lead a large-scale global phase III clinical trial for a new class of anti-platelet heart medication for patients who have had a heart attack, stroke or existing peripheral arterial disease. The medication, thrombin receptor antagonist (TRA/SCH 530348), a new type of anti-platelet agent with a potential for less risk of bleeding than with other platelet blockers, is being developed by Schering-Plough Corporation. The BWH trial will evaluate the reduction in risk of experiencing a serious cardiovascular event among participants taking TRA compared to participants who receive placebo plus standard-of-care (including aspirin and/or clopidogrel).
The clinical trial will be conducted by the Thrombolysis in Myocardial Infarction (TIMI) Study Group at BWH and will assess whether TRA reduces the risk of cardiovascular death, heart attack or stroke among approximately 19,500 participants who have previously experienced one of those coronary events, or have existing peripheral arterial disease. This trial, Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2P-TIMI 50) is a randomized, multi-national, double-blind placebo controlled study that will be conducted in more than 800 sites in approximately 30 countries. Participants will be followed for a minimum of one year.
Dr. David Morrow, an investigator with the TIMI Study Group at BWH, Principal Investigator of the Phase III TRA 2P-TIMI 50 trial and Assistant Professor of Medicine at Harvard Medical School commented, "Patients who have had a heart attack, or stroke are at high risk for having another potentially life-threatening cardiovascular event. It is an important goal of treatment to reduce that risk without the high incidence of bleeding that frequently accompanies currently available therapies."
In addition to the BWH TRA 2P-TIMI 50 trial, the phase III program will include a trial conducted by the Duke Clinical Research Institute to evaluate TRA/SCH 530348 in patients with acute coronary syndrome. The Phase II TRA-PCI Trial recently presented at the annual Scientific Sessions of the American College of Cardiology/i2 Summit in New Orleans met its primary endpoint of demonstrating no increase in major and minor bleeding, according to the TIMI bleeding scale, when this investigational antiplatelet compound was added to standard antiplatelet therapy (including aspirin and clopidogrel) among patients undergoing percutaneous coronary intervention (PCI).
TRA/SCH 530348 is being developed as a member of a new class of anti-platelet medications called thrombin receptor antagonists. The U.S. Food and Drug Administration had previously granted Fast Track status to the drug which allows them to speed up review of drugs for life-threatening conditions that demonstrate the potential to address unmet medical needs.
For more information contact BWH Media Relations at BWHMediaRelations@partners.org or (617) 534-1600.
Brigham and Women's Hospital (BWH) is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 800 physician-investigators and renowned biomedical scientists and faculty supported by more than $400M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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