Status:
COMPLETED
The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
Lead Sponsor:
Sanofi
Conditions:
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation mark...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Due to undergo non-urgent percutaneous coronary intervention (PCI)
- Planned treatment with aspirin and clopidogrel
Exclusion
- Recent acute coronary syndrome
- Patients at risk for, or with prior recent, bleeding
- Patients have received recent prior treatment with an anticoagulant
- Creatinine clearance \> 30 ml/min
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
947 Patients enrolled
Trial Details
Trial ID
NCT00133731
Start Date
September 1 2004
End Date
October 1 2005
Last Update
July 2 2008
Active Locations (89)
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1
Los Angeles Cardiology Associates
Los Angeles, California, United States, 90017
2
Anil V. Shah, MD
Santa Ana, California, United States, 92704
3
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
4
Florida Cardiovascular Research
Atlantis, Florida, United States, 33462