Sanofi/B-MS publish Plavix trial design

French drug major Sanofi-Aventis and the USA's Bristol-Myers Squibb have 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 who are intended to undergo intervention with coronary angioplasty in the American Heart Journal.

The study is a Phase III, multicenter, multinational, randomized, parallel-group trial planned to enroll 18,000 to 20,000 patients who present with ACS symptoms to an emergency department, emergency ward or coronary care unit, and are scheduled to undergo early invasive strategy with intent to perform percutaneous coronary intervention as early as possible and no later than 72 hours after randomization. As soon as possible after presentation and enrollment, patients will be randomized to Plavix in either a high-dose regimen (600mg loading dose on day 1, as early as possible before coronary angiography, then 150mg once daily through day seven, then 75mg once daily until day 30), or a standard-dose regimen (300mg loading dose on day one, then 75mg once daily until day 30). Patients also are randomly assigned, but in open-label fashion, to aspirin in either a high-dose (300mg-325mg once daily) or low-dose regimen (75mg-100mg once daily).

The primary outcome of the trial will be the composite of death from cardiovascular causes, myocardial (re-) infarction or stroke up to day 30. The primary safety outcome will be major bleeding. Secondary outcomes will include individual rates of cardiovascular death, total death, myocardial infarction (including around the time of the procedure), stroke (any type), recurrent ischemia, urgent revascularization and stent thrombosis. Findings are expected to be ready for presentation in the first half of 2009.