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

Phase 2

Completed

• Conditions: Coronary Disease
• Interventions: Drug: Otamixaban (XRP0673); Drug: unfractionated heparin; Drug: eptifibatide

• Registration Number: NCT00317395
• Lead Sponsor: Sanofi

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-21
• Study First Submitted QC: 2006-04-21
• Study First Posted: 2006-04-24
• Study Start: 2006-06
• Primary Completion: 2008-10
• Study Completion: 2009-03
• Disposition First Submitted: 2010-08-24
• Disposition First Submitted QC: 2010-08-24
• Disposition First Posted: 2010-08-27
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3241

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Otamixaban Dose 1	Otamixaban (XRP0673)	dosage regimen 1
Otamixaban Dose 3	Otamixaban (XRP0673)	dosage regimen 3
Otamixaban Dose 5	Otamixaban (XRP0673)	dosage regimen 5
Otamixaban Dose 2	Otamixaban (XRP0673)	dosage regimen 2
Otamixaban Dose 4	Otamixaban (XRP0673)	dosage regimen 4
UFH/Eptifibatide	unfractionated heparin	-
UFH/Eptifibatide	eptifibatide	-

Primary Outcome Measures

Name	Time	Method
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor	within 7 days following randomization

Secondary Outcome Measures

Name	Time	Method
Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding	within 7 days and 30 days following randomization
Incidence of TIMI significant bleeding	within 7 days following randomization
Incidence of all bleedings	within 7 days and 30 days following randomization
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor	within 30 days, 90 days and 180 days following randomization

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇷 Istanbul, Turkey