Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.

Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Calcium heparin; Eptifibatide; Heparin; Otamixaban

Criteria

Inclusion Criteria:

• Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization

• Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (> upper limit of normal [ULN])

• No ST elevation Myocardial Infarction (STEMI)

• Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3

Exclusion Criteria:

• Inability to undergo coronary angiography or PCI by Day 3

• Prior PCI within 30 days

• Acute STEMI

• Cardiogenic shock

• Anticoagulant treatment for > 24 hours prior to randomization

• Prior treatment with fondaparinux since ACS onset

• Requirement for oral anticoagulant (OAC) prior to Day 30

• Creatinine clearance < 30 ml/min