Health Condition 1: null- "Unstable angina/Non ST segment Elevation Myocardial infarction" Health Condition 2: I222- Subsequent non-ST elevation (NSTEMI) myocardial infarction
Conditions
Interventions
Intervention1: otamixaban
: Route of administration: Intravenous: Continuous infusion.
Bolus of 0.080 mg/Kg followed by an IV infusion of 0.100 mg/Kg/hr
or IV infusion of 0.140 mg/Kg/hr.
Control Inte
Sponsors
SanofiSynthelabo India Limited
Eligibility
Inclusion criteria
Inclusion criteria: "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 ( 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 Exclusion Criteria: 1. Exclusion criteria related to study methodology A. General 1. High likelihood of being unavailable for the Day 180 follow up 2. Age 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 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 "
Exclusion criteria
Exclusion criteria: "Exclusion criteria related to study methodology Any major orthopedic surgery in the 3 months prior to study start Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome Patients at high risk of bleeding Known allergy to heparin - or enoxaparin Any contra-indications to the performance of venography "
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarctionTimepoint: from randomization (day 1) to day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| "1)Triple efficacy composite of all-cause death, new myocardial infarction and any stroke from randomization (Day 1) to Day 7 2)Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction from randomization (Day 1 to Day 30) 3)Adjudicated all-cause Death from randomization (Day 1) to Day 30 4)Procedural thrombotic complications during the index PCI." Timepoint: "1) For the 1st secondary outcome, the time point is from randomization (Day 1) to Day 7 2)For the 2nd secondary outcome, the time point is fromDay 1 to Day 30 3) For the 3rd secondary outcome, the time point is from randomization (Day 1) to Day 30 4) For the 4th secondary outcome, the time point is during the index PCI." | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, The former Yugoslav Republic of Macedonia, Tunisia, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactRajiv De
Sanofi Synthelabo (India) Ltd
Outcome results
None listed