The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary
- Registration Number
- NCT00133731
- Lead Sponsor
- Sanofi
- 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 markers), safety/tolerability, clinical efficacy and pharmacokinetics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 947
- 18 years of age or older
- Due to undergo non-urgent percutaneous coronary intervention (PCI)
- Planned treatment with aspirin and clopidogrel
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
- Secondary Outcome Measures
Name Time Method Bleeding events
Related Research Topics
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Trial Locations
- Locations (89)
Los Angeles Cardiology Associates
🇺🇸Los Angeles, California, United States
Anil V. Shah, MD
🇺🇸Santa Ana, California, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Florida Cardiovascular Research
🇺🇸Atlantis, Florida, United States
Ocala Research Institute, Inc
🇺🇸Ocala, Florida, United States
Central Florida Cardiology Group, PA
🇺🇸Orlando, Florida, United States
Cardiology Associates, PA
🇺🇸Panama City, Florida, United States
Heart Specialists of Sarasota
🇺🇸Sarasota, Florida, United States
Cardiac Disease Specialists
🇺🇸Atlanta, Georgia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Scroll for more (79 remaining)Los Angeles Cardiology Associates🇺🇸Los Angeles, California, United States