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

Sponsor: Sanofi-Aventis, October 2010

Purpose

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

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Otamixaban (XRP0673) Drug: Otamixaban matching placebo Drug: Unfractionated Heparin Drug: Unfractionated Heparin matching placebo Drug: Eptifibatide Drug: Eptifibatide matching placebo	Phase III

Study Type: Interventional

Estimated Enrollment: 13220

Estimated Study Completion Date: June 2012

Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Detailed Description:
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.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
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.
• Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing
• Patients 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

Contacts and Locations

Physicians:
Ameer Kabour, MD
Raza Hashmi, MD
Tarif Kanaan, MD
Mohammad Alkhateeb, MD

Coordinators:
Michelle Hickam, RN, BSN
Brenda Hoagland, RN, CCRC
Julie Neidhardt, RN, BSN

Please contact us at 419-251-4919 for further information about this study.

Information obtained from www.clinicaltrials.gov