Rationale and Design of Current-Oasis 7 Study Published in American Heart Journal
- One of the Largest Outcomes Trials In Coronary Intervention ACS Patients Will Evaluate Efficacy and Safety of Higher Loading and Initial Maintenance Doses of Plavix® -
Sanofi-aventis (NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the American Heart Journal published the rationale and design of the ongoing CURRENT-OASIS 7 trial, a study evaluating the effects of standard and higher-dosing regimens of Plavix® (clopidogrel bisulfate) and aspirin on cardiovascular outcomes and bleeding complications in patients with acute coronary syndrome (ACS) who are intended to undergo intervention with coronary angioplasty.
CURRENT-OASIS 7 (Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS) will enroll between 18,000-20,000 patients, making it one of the largest studies ever conducted in this patient population.
“CURRENT-OASIS 7 will provide critical information on whether the effects of a more intensive clopidogrel loading dose and initial maintenance regimen is superior to the standard treatment of ACS patients undergoing Percutaneous Coronary Intervention (PCI) and may improve outcomes,” said principal investigator Shamir R Mehta, MD, MSc, McMaster University/Hamilton Health Sciences. “The patients in this trial are being treated with study medication early after symptom onset, as recommended by several U.S. and European expert committee guidelines. Additionally, the trial will add to our understanding of aspirin dosing post-PCI and the effects of a higher loading dose regimen of Plavix® on outcomes such as stent thrombosis.”
Findings from CURRENT-OASIS 7, sponsored by sanofi-aventis and Bristol-Myers Squibb, are anticipated for presentation in the first half of 2009.
Antiplatelet therapy with Plavix® (clopidogrel bisulfate) and aspirin reduces major cardiovascular events in ACS patients during and after coronary angioplasty, also referred to as percutaneous coronary intervention or PCI. The Plavix® dosing regimen currently indicated for ACS patients treated by PCI is a 300 mg loading dose, followed by 75 mg per day, along with 75-325 mg per day of aspirin. The results of this study will have relevance to clinical practice and guideline recommendations.
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