New Large-Scale, Global Study Provides Additional Information About an Intensified Dose-Regimen of PLAVIX(R) in Acute Coronary Syndrome Patients Undergoing A...( ...),Health

PARIS, and PRINCETON, N.J., Aug. 30 /PRNewswire/ -- Today, the OASIS study group will present initial results of the CURRENT-OASIS 7 clinical trial at the European Society of Cardiology congress in Barcelona. Sanofi-aventis (EURONEXT: SAN, and NYSE: SNY) and Bristol-Myers Squibb (NYSE: BMY), co-commercialization and co-development partners for PLAVIX((R)) (clopidogrel bisulfate), were sponsors of the study.

CURRENT-OASIS 7 is the largest clinical trial (25,087 patients) to evaluate different dosing regimens of PLAVIX((R)) plus aspirin in a broad range of acute coronary syndrome (ACS) patients (UA/NSTEMI/STEMI). The study was designed to assess the efficacy and safety of an intensified clopidogrel regimen (600 mg loading dose day 1 / 150 mg days 2-7 / 75 mg days 8-30) versus the approved PLAVIX dosage (300 mg loading dose day 1 / 75 mg days 2-30) for patients managed with an early invasive strategy with an intent for percutaneous coronary intervention (PCI).

The primary end-point (cardiovascular death, heart attack, or stroke at thirty days) for the entire study population (including subpopulations of patients that underwent PCI (70%) or not (30%) examining the difference between the high-dose and standard-dose PLAVIX((R)) (clopidogrel bisulfate) regimens did not reach statistical significance (4.2% vs. 4.4%, HR 0.95, p=0.37).

For clinically relevant subgroups that were pre-specified for preliminary analyses, such as the PCI subgroup (70% of the trial population, 17,232 patients), potentially medically relevant differences in patient outcomes were observed. In this subgroup, analysis showed an improvement in outcome fo
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