Overview

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

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Calcium heparin
Heparin
Otamixaban
Criteria
Inclusion Criteria:

- 18 years of age or older

- Due to undergo non-urgent percutaneous coronary intervention (PCI)

- Planned treatment with aspirin and clopidogrel

Exclusion Criteria:

- 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