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

Sanofi3,241 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

3,241

Conditions

Coronary Disease

Interventions

Otamixaban (XRP0673)DRUG

intravenous administration

unfractionated heparinDRUG

intravenous administration

eptifibatideDRUG

intravenous administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (36)

Outcomes

Primary Outcomes

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

Time frame: within 7 days following randomization

Secondary Outcomes

Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding

Time frame: within 7 days and 30 days following randomization

Time frame: within 30 days, 90 days and 180 days following randomization

Incidence of TIMI significant bleeding

Time frame: within 7 days following randomization

Incidence of all bleedings

Time frame: within 7 days and 30 days following randomization

Data from ClinicalTrials.gov

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