Treatment of Acute Coronary syndrome with Otamixaban (TAO)
- Conditions
- Health Condition 1: null- Unstable angina/Non ST segment Elevation MyocardialinfarctionHealth Condition 2: I222- Subsequent non-ST elevation (NSTEMI) myocardial infarction
- Registration Number
- CTRI/2010/091/000233
- Lead Sponsor
- SanofiSynthelabo India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10930
Inclusion Criteria: Patient with non STE-segment elevation Acute Coronary Syndrome with the following
symptoms:
Ischemic symptoms (chest pain or equivalent) at rest ≥10 minutes within 24 hours of randomization
AND
One of the two following criteria:
A. New ST-segment depression ≥0.1 mV (≥1 mm), or transient ( <30 minutes) STsegment elevation ≥0.1 mV (≥1 mm) in at least 2 contiguous leads on the ECG, OR
B. 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
1. Exclusion criteria related to study methodology
A. General
1. High likelihood of being unavailable for the Day 180 follow up
2. Age <18 years old (or country?s legal age of majority)
3. Pregnancy, as evidenced by a positive urine pregnancy test performed prior to randomization (applicable only to women of childbearing potential, ie, women who are pre-menopausal or <2 years post-menopausal)
4. Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization, or planned use of investigational agents or devices during the study duration
5. Breastfeeding
B. Cardiovascular
6. Revascularization procedure already performed for the qualifying event.
7. Acute ST-segment elevation MI
C. Related to prior or concomitant treatments
8. Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization.
9. Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing
10. Patients who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling
2. Exclusion criteria related to the active comparator and/or mandatory background therapies
A. Related to eptifibatide
11. 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 will be either the European labeling or the US labeling (see Appendix H and Appendix I). B. Related to unfractionated heparin
12. Patient who cannot be treated with unfractionated heparin according to the national labeling
C. Related to otamixaban
13. Allergy to otamixaban
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarctionTimepoint: from randomization (day 1) to day 7
- Secondary Outcome Measures
Name Time Method 1)Triple efficacy composite of all-cause death, new myocardial infarction and any stroke from randomization (Day 1) to Day 7 <br/ ><br>2)Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction from randomization (Day 1 to Day 30) <br/ ><br>3)Adjudicated all-cause Death from randomization (Day 1) to Day 30 <br/ ><br>4)Procedural thrombotic complications during the index PCI. <br/ ><br>Timepoint: 1) For the 1st secondary outcome, the time point is from randomization (Day 1) to Day 7 <br/ ><br>2)For the 2nd secondary outcome, the time point is fromDay 1 to Day 30 <br/ ><br>3) For the 3rd secondary outcome, the time point is from randomization (Day 1) to Day 30 <br/ ><br>4) For the 4th secondary outcome, the time point is during the index PCI. <br/ ><br>