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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Angioplasty, Transluminal, Percutaneous Coronary

Treatments: Drug: Unfractionated Heparin; Drug: Otamixaban (XRP0673); Procedure: Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT00133731

DRI6199

XRP0673

Details and patient eligibility

About

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.

Enrollment: 947 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind