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Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study
Date:3/12/2009

hion based on a blinded review by a Safety Review Committee. Those patients who subsequently underwent PCI (n=573) were randomized to one of three oral daily maintenance doses of TRA (0.5mg, 1.0mg, 2.5mg) plus standard of care (aspirin and clopidogrel) for those who had received a TRA loading dose, or randomized to placebo plus standard of care for those who had received a placebo loading dose. The total duration of treatment was 60 days, and patients were followed for an additional 120 days post-enrollment.

The primary endpoint was measured using the TIMI bleeding scale. TIMI major bleeding is defined as any intracranial (head) hemorrhage or overt sign of bleeding associated with a decrease in hemoglobin concentration of greater than 50 g/L (or hematocrit greater than 15 percent). TIMI minor bleeding is defined as an overt sign of bleeding that does not meet the requirements for TIMI major bleed, associated with a decrease in hemoglobin concentration of 30g/L to less than or equal to 50 g/L (or hematocrit 9-15 percent).

Study Results

In the primary cohort, i.e., patients treated with PCI, the incidence of TIMI major and minor bleeding was 3 percent in both the collective TRA treatment arms and the current standard care alone arm (p=0.7713). Non-TIMI bleeding was also not significantly increased with TRA compared to current standard care alone (p=0.0650). Overall, TRA was well tolerated, with discontinuations due to any adverse events (mostly non-TIMI bleeding and non-specific gastrointestinal symptoms, e.g., nausea) of 6 percent compared to 4 percent with placebo. Although not statistically significant, the incidence of death or major adverse cardiac event (MACE) at 60 days was 9 percent in the placebo group compared to 6 percent across all TRA dosages (33 percent reduction). The reduction in MACE was predominantly due to a reduction in myocardial infarction (heart attack), 7 percent with placebo compared to 4
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SOURCE Schering-Plough Corporation
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