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Schering-Plough Announces Results of the Early ACS Trial
Date:3/30/2009

ed upon enrollment, followed by greater than or equal to 75 mg daily thereafter. Thienopyridine was substituted in aspirin-intolerant patients. The protocol mandated either weight-based unfractionated heparin or weight- and renal-adjusted enoxaparin by investigator choice. After a study amendment, bivalirudin and fondaparinux were allowed as concomitant baseline antithrombotic therapies. If early clopidogrel was used, the recommended loading dose was 300 mg. A 600 mg loading dose was permitted peri-PCI if no prior loading dose had been administered. The recommended clopidogrel maintenance dose was 75 mg daily.

The primary efficacy endpoint was a composite of all-cause mortality, (re)MI, recurrent ischemia requiring urgent revascularization, or thrombotic bailout through 96 hours. The key secondary efficacy endpoint was 30-day death or (re)MI. Safety endpoints included rates of hemorrhage, transfusion, surgical re-exploration, stroke, thrombocytopenia, and serious adverse events through 120 hours. Bleeding was measured according to the TIMI and GUSTO bleeding scales.

About INTEGRILIN(R) (eptifibatide) Injection

INTEGRILIN is indicated for the treatment of patients with acute coronary syndrome (unstable angina/non-ST-segment-elevation myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). It is also indicated in the United States for the treatment of patients undergoing PCI, including those undergoing intracoronary stenting.

INTEGRILIN is contraindicated in patients with a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days; severe hypertension (systolic blood pressure greater than 200 mm Hg or diastolic blood pressure greater than 110 mm Hg) not adequately controlled on antihypertensive therapy; major surgery within the preceding six weeks; history of stroke within 30 days,
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SOURCE Schering-Plough
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