The purpose of this study is to test whether SR123781A is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of SR123781A are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,257
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
Buenos Aires, Argentina
Sanofi-Aventis
Macquarie Park, Australia
Efficacy: composite of all causes of death, new myocardial infarction, or severe myocardial ischemia requiring urgent repeat target vessel revascularization within 7 days following randomization.
Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
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Sanofi-Aventis
Diegem, Belgium
Sanofi-Aventis
São Paulo, Brazil
Sanofi-Aventis
Laval, Quebec, Canada
Sanofi-Aventis
Providencia, Santiago Metropolitan, Chile
Sanofi-Aventis
Prague, Czechia
Sanofi-Aventis France
Paris, France
Sanofi-Aventis
India, India
...and 8 more locations