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

Completed · Phase 2

Conditions studied: Coronary Disease

In brief

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).

Key facts

Study ID

NCT00317395

Run by

Sanofi

People needed

3241

Starts

2006-06-01

Expected to finish

2009-03-01

Last updated by the study team

2014-12-03

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Sofia, Bulgaria
• Sanofi-Aventis Administrative Office — Laval, Quebec, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Cali, Colombia
• Sanofi-Aventis Administrative Office — Zagreb, Croatia
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Tatari, Estonia
• Sanofi-Aventis Administrative Office — Helsinki, Finland
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Mumbai, India
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Kuala Lumpur, Malaysia
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Porto Salvo, Portugal

Full record on ClinicalTrials.gov

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