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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy

Conditions
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Coronary Disease

Intervention / Treatment
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* Drug: Otamixaban (XRP0673)
* Drug: unfractionated heparin
* Drug: eptifibatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Otamixaban Dose 1<br>dosage regimen 1 | Drug: Otamixaban (XRP0673)<br>* intravenous administration<br>|
| Experimental: Otamixaban Dose 2<br>dosage regimen 2 | Drug: Otamixaban (XRP0673)<br>* intravenous administration<br>|
| Experimental: Otamixaban Dose 3<br>dosage regimen 3 | Drug: Otamixaban (XRP0673)<br>* intravenous administration<br>|
| Experimental: Otamixaban Dose 4<br>dosage regimen 4 | Drug: Otamixaban (XRP0673)<br>* intravenous administration<br>|
| Experimental: Otamixaban Dose 5<br>dosage regimen 5 | Drug: Otamixaban (XRP0673)<br>* intravenous administration<br>|
| Active Comparator: UFH/Eptifibatide<br> | Drug: unfractionated heparin<br>* intravenous administration<br>Drug: eptifibatide<br>* intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Incidence of TIMI significant bleeding |  | within 7 days following randomization | 
| Incidence of all bleedings |  | within 7 days and 30 days following randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non ST elevation Acute Coronary Syndrome, Early invasive strategy, Percutaneous Coronary Intervention