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SCH 530348 (TRA), a Novel Investigational Antiplatelet Agent, Shown to Inhibit Platelet Aggregation in PCI Patients
Date:11/7/2007

in New Orleans.

Study Results

IPA responses to the thrombin receptor agonist peptide (TRAP), adenosine diphosphate (ADP), collagen and arachidonic acid (AA) were measured using light transmission aggregometry at baseline and 30, 60, 90 and 120 minutes following a loading dose (10, 20 or 40 mg vs. placebo) and after a maintenance dose (0.5, 1.0 or 2.5 mg/day) at 30 and 60 days. PK was assessed at 30 and 60 minutes and 2 hours after loading dose administration.

TRA was active in inhibiting 15.M TRAP-induced platelet aggregation with onset of inhibition directly related to dose. The 40 mg loading dose resulted in 96.3 percent of patients achieving greater than 80 percent TRAP-induced platelet aggregation inhibition within two hours, compared with 52.9 percent of patients for the 20 mg loading dose and 42.9 percent of patients for the 10 mg loading dose.

The sub-study demonstrated that for the 1.0 mg and 2.5 mg maintenance dose groups, all patients exhibited greater than 80 percent IPA at both 30 and 60 days. Placebo-treated patients had, on average, less than or equal to 10 percent IPA to TRAP.

TRA had no significant effects on ADP, collagen or AA-induced platelet aggregation compared with placebo.

About the Phase III Trials

The Phase III Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2P-TIMI 50) trial is a multinational, randomized, double-blind, placebo-controlled study in approximately 19,500 patients with prior MI or stroke, as well as patients with existing peripheral arterial disease. Patients will be randomized to either placebo plus standard medical care (including aspirin and clopidogrel) or to TRA once daily plus standard medical care. This Phase III trial will use the 2.5 mg maintenance dose. The primary endpoint of the trial is the composite of cardiovascular death, MI, urgent coronary revascularization or stroke. The key secondary endpoint is the composite of cardiovas
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SOURCE Schering-Plough Corporation
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