News Release

Novel platelet therapy may reduce PCI complications

Peer-Reviewed Publication

American College of Cardiology

Despite the availability of numerous anti-thrombotic therapies today, adverse events following percutaneous coronary intervention (PCI) such as late-stent thrombosis are still a major concern for cardiologists, and there is a need for medications that can minimize the risk of these complications but also manage the rate of bleeding. A study presented today at the American College of Cardiology’s Innovation in Intervention: i2 Summit evaluates the safety and efficacy of a novel oral thrombin receptor antagonist in reducing PCI complications. Innovation in Intervention: i2 Summit is an annual meeting for practicing cardiovascular interventionalists sponsored by the American College of Cardiology in partnership with the Society for Cardiovascular Angiography and Interventions.

Researchers at the University of Kentucky, Gill Heart Institute and Duke Clinical Research Institute led a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the oral thrombin receptor antagonist (TRA) SCH 530348 among 1,030 patients at sites across North America and Europe. TRA is a potentially new class of drug that blocks the impact of thrombin (the most potent platelet agonist) on the platelet.

A total of 1,030 patients were randomized in a 3:1 ratio to a 10, 20 or 40 mg loading dose of SCH 530348 or placebo. Of the total patient population, 573 underwent PCI (primary cohort) while 75 underwent CABG and 382 received medical management. Patients undergoing PCI (primary cohort) were further randomized to a 0.5, 1.0, or 2.5 mg daily maintenance dose of SCH 530348 or to placebo (depending on loading therapy) for 60 days. Patients also received other standard therapies, including aspirin, clopidogrel and an antithrombin. Primarily, researchers were looking for any major adverse events in the study population as well as bleeding risks. Secondary endpoints included the composite of death and major adverse cardiac events.

Overall, treatment with TRA offered an improvement in adverse event rates in the study population without an increase in bleeding risk. Results show that major TIMI was reduced in the low dose cohorts of TRA patients as compared to placebo (1.6% compared to 3.3%), The highest dosage TRA treated populations fared best in overall death or major adverse events compared to placebo (4.6% vs. 8.6%), as well as heart attack risk (3.5% vs. 7.3%).

"TRA has the potential to be a transformational antiplatelet therapy for the treatment of atherothrombosis," said David Moliterno, M.D., of the University of Kentucky Gill Heart Institute and lead author of the study. "As we continue to evaluate this in combination with other cardiac interventions, we hope to study this compound in large-scale Phase 3 trials."

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Dr. Moliterno will present the results of this study on Saturday, March 24, “Results of a Multinational Randomized, Double-Blind, Placebo-Controlled Study of a Novel Thrombin Receptor Antagonist SCH 530348 in Percutaneous Coronary Intervention” at 11:00 a.m. in room La Nouvelle Orleans C.

The American College of Cardiology (www.acc.org) represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.07 and the i2 Summit is the largest cardiovascular meeting, bringing together cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.


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