Status:
COMPLETED
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Lead Sponsor:
Sanofi
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous \[IV\] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (...
Eligibility Criteria
Inclusion
- Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization
- Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (\> upper limit of normal \[ULN\])
- No ST elevation Myocardial Infarction (STEMI)
- Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3
Exclusion
- Inability to undergo coronary angiography or PCI by Day 3
- Prior PCI within 30 days
- Acute STEMI
- Cardiogenic shock
- Anticoagulant treatment for \> 24 hours prior to randomization
- Prior treatment with fondaparinux since ACS onset
- Requirement for oral anticoagulant (OAC) prior to Day 30
- Creatinine clearance \< 30 ml/min
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
3241 Patients enrolled
Trial Details
Trial ID
NCT00317395
Start Date
June 1 2006
End Date
March 1 2009
Last Update
December 3 2014
Active Locations (36)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Vienna, Austria
4
Sanofi-Aventis Administrative Office
São Paulo, Brazil