Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction
Phase 2
Completed
- Conditions
- Coronary Atherosclerosis
- Registration Number
- NCT00123565
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1257
Inclusion Criteria
- A person with a diagnosis of acute coronary syndrome who is scheduled to undergo a PCI within 48 hours.
- A person who is of the legal age of 21, who is mentally competent, and who has signed a written informed consent
Exclusion Criteria
- A person with known allergy or any contra-indication to active control.
- A person who has received heparin during more than 48 hours before inclusion in the study.
- A person treated with warfarin (oral anticoagulant).
- A person with current bleeding or recognized increased risk of bleeding or history of intracranial hemorrhage.
- A person who has had a stroke within the last 6 months.
- A person with uncontrolled hypertension despite antihypertensive therapy.
- A person with history of clinically significant reduction in blood platelets or neutrophils (white blood cells).
- A person who has laboratory evidence of significantly reduced renal function or who is dependent on renal dialysis.
- A person who has a coronary bypass performed during the previous month.
- A pregnant or nursing woman or a woman of childbearing potential (before menopause) who does not have a negative pregnancy test and does not use a reliable method of birth control.
- A person who has received any investigational treatment in the preceding month.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
Trial Locations
- Locations (3)
Sanofi-Aventis
🇹🇷Istanbul, Turkey
Sanofi-Aventis France
🇫🇷Paris, France
Sanofi-aventis
🇪🇸Barcelona, Spain