Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome (SEPIA-ACS1)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Coronary Disease

Treatments: Drug: eptifibatide; Drug: unfractionated heparin; Drug: Otamixaban (XRP0673)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00317395

DRI6624

2006-000506-22 (EudraCT Number)

XRP0673A/2003 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 3,241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,241 participants in 6 patient groups

Otamixaban Dose 1

Experimental group

Description:

dosage regimen 1

Treatment:

Drug: Otamixaban (XRP0673)

Otamixaban Dose 2

Experimental group

Description:

dosage regimen 2

Treatment:

Drug: Otamixaban (XRP0673)

Otamixaban Dose 3

Experimental group

Description:

dosage regimen 3

Treatment:

Drug: Otamixaban (XRP0673)

Otamixaban Dose 4

Experimental group

Description:

dosage regimen 4

Treatment:

Drug: Otamixaban (XRP0673)

Otamixaban Dose 5

Experimental group

Description:

dosage regimen 5

Treatment:

Drug: Otamixaban (XRP0673)

UFH/Eptifibatide

Active Comparator group

Treatment:

Drug: eptifibatide

Drug: unfractionated heparin