Status:
COMPLETED
Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction
Lead Sponsor:
Sanofi
Conditions:
Coronary Atherosclerosis
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 interventi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
1257 Patients enrolled
Trial Details
Trial ID
NCT00123565
Start Date
December 1 2004
End Date
May 1 2007
Last Update
August 21 2008
Active Locations (18)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States
2
Sanofi-Aventis
Buenos Aires, Argentina, 1642
3
Sanofi-Aventis
Macquarie Park, Australia, NSW 2113
4
Sanofi-Aventis
Diegem, Belgium, 18 31