Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy (TAO)
Acute Coronary Syndrome
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
- 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion
UFH + Eptifibatide
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: Drug C: Placebo (for Eptifibatide)
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: Drug C: Placebo (for Eptifibatide)
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: Drug A: Placebo (for Otamixaban) Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)