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An oral thrombin receptor antagonist demonstrated no increase in major or minor bleeding when added to standard antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI), according to phase 2 trial results.
An oral thrombin receptor antagonist demonstrated no increase in major or minor bleeding when added to standard antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI), according to the results of a phase 2 clinical trial.
These results were presented at the 56th Annual Scientific Session of the American College of Cardiology (ACC).
The agent, SCH 530348, was studied in 1,030 patients who were considered for nonurgent PCI (of whom 573 subsequently underwent PCI) and were being treated with antithrombotic therapy (heparin or direct thrombin inhibitor) and antiplatelet therapy (aspirin and clopidogrel). Patients were randomized to a 10-, 20-, or 30-mg loading dose of SCH 530348 or placebo. The 573 patients who underwent PCI were further randomized to daily maintenance doses of 0.5, 1.0, or 2.5 mg or placebo for 60 days.
Among the patients who underwent PCI, the rates of TIMI major or minor bleeding were 2.8% in the pooled SCH 530348 groups compared with 3.3% in the placebo group, said lead investigator David J. Moliterno, MD, chief of cardiovascular medicine, University of Kentucky, Lexington.
Although the study was not powered for clinical outcomes, death or major adverse cardiac events (myocardial infarction [MI], ischemia requiring hospitalization, or coronary revascularization) occurred in 6.2% of patients in the SCH 530348 cohort compared with 8.6% of patients in the placebo group. The event rate was 46% lower among patients receiving the 40- mg/d dose of SCH 530348 compared with placebo, although this reduction did not achieve statistical significance.
Dr Moliterno said that SCH 530348 should be studied in large-scale phase 3 clinical trials in combination with other cardiac interventions.