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

Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the
control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized
to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on
interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all
participants will remain blinded to this decision until the end of study.

The total duration of the study period per subject will range between 30 days and 180 days.
Study end date being the Day 30 visit of the last randomized patient, follow up will be
until Day 180 or study end date whichever comes first.

Inclusion criteria:

Patient with non ST-segment elevation Acute Coronary Syndrome with:

1. Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of
randomization,

AND

2. 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

3. 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

4. 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.