The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention

Completed · Phase 2

Conditions studied: Angioplasty, Transluminal, Percutaneous Coronary

In brief

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.

Key facts

Study ID

NCT00133731

Run by

Sanofi

People needed

947

Starts

2004-09-01

Expected to finish

2005-10-01

Last updated by the study team

2008-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Due to undergo non-urgent percutaneous coronary intervention (PCI)
• Planned treatment with aspirin and clopidogrel

You may not qualify if…

• 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

Where it is running

• Anil V. Shah, MD — Santa Ana, California, United States
• George Washington University Medical Faculty Associates — Washington D.C., 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
• Rush University Medical Center — Chicago, Illinois, United States
• Midwest Heart Foundation — Lombard, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Heart Care Midwest — Peoria, Illinois, United States
• Prairie Cardiovascular Consultants, Ltd — Springfield, Illinois, United States
• The Care Group, LLC — Indianapolis, Indiana, United States
• Iowa Heart Center, PC — Des Moines, Iowa, United States
• Kansas Cardiology Associates — Wichita, Kansas, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• LeBauer Cardiovascular Research Foundation — Greensboro, North Carolina, United States
• Wake Heart Associates — Raleigh, North Carolina, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Los Angeles Cardiology Associates — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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