Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Coronary Syndrome

In brief

Primary Objective: * To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: * To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide * To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide * To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide * To document the safety of Otamixaban as compared to UFH + eptifibatide * To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

Key facts

Study ID

NCT01076764

Run by

Sanofi

People needed

13220

Starts

2010-04-01

Expected to finish

2013-05-01

Last updated by the study team

2016-05-04

Who can join

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

You may qualify if…

• Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with:
• Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,
• AND
• One of the two following criteria:
• New ST-segment depression ≥ 0.1 mV (≥1 mm), or transient (< 30 minutes) ST-segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram,
• Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal,
• AND
• Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified),
• AND
• Informed consent obtained in writing.

You may not qualify if…

• Revascularization procedure already performed for the qualifying event Acute ST-segment elevation MI.
• Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization or who have been treated by abciximab.
• Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing.
• Patient who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling.
• Patient who cannot be treated with eptifibatide according to the national labeling (when available). In countries where eptifibatide is not approved the reference label to be considered is either the European labeling or the US labeling
• Patient who cannot be treated with unfractionated heparin according to the national labeling.
• Allergy to otamixaban.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840569 — Phoenix, Arizona, United States
• Investigational Site Number 840703 — Phoenix, Arizona, United States
• Investigational Site Number 840101 — Anaheim, California, United States
• Investigational Site Number 840151 — Anaheim, California, United States
• Investigational Site Number 840213 — Beverly Hills, California, United States
• Investigational Site Number 840572 — Huntington Beach, California, United States
• Investigational Site Number 840201 — Long Beach, California, United States
• Investigational Site Number 840071 — Los Angeles, California, United States
• Investigational Site Number 840557 — Los Angeles, California, United States
• Investigational Site Number 840903 — Northridge, California, United States
• Investigational Site Number 840065 — San Francisco, California, United States
• Investigational Site Number 840561 — Santa Rosa, California, United States
• Investigational Site Number 840721 — Littleton, Colorado, United States
• Investigational Site Number 840551 — Bridgeport, Connecticut, United States
• Investigational Site Number 840166 — New Haven, Connecticut, United States
• Investigational Site Number 840520 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840185 — Fort Lauderdale, Florida, United States
• Investigational Site Number 840028 — Jacksonville, Florida, United States
• Investigational Site Number 840047 — Lake Mary, Florida, United States
• Investigational Site Number 840500 — Melbourne, Florida, United States
• Investigational Site Number 840706 — Miami, Florida, United States
• Investigational Site Number 840009 — Ocala, Florida, United States
• Investigational Site Number 840146 — Ocala, Florida, United States
• Investigational Site Number 840577 — Orlando, Florida, United States
• Investigational Site Number 840015 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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