Acute coronary syndrome scheduled to undergo an early invasive strategy. MedDRA version: 12.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Product Name: Otamixaban
Product Code: XRP0673
Pharmaceutical Form: Solution for injection
INN or Proposed INN: otamixaban
CAS Number: 219672-50-1
Current Sponsor code: XRP0673
Concentration unit: mg/
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with non ST-segment elevation Acute Coronary Syndrome with the following symptoms: I 01. Ischemic symptoms (chest pain or equivalent) at rest =10 minutes within 24 hours of randomization AND I 02.One of the two following criteria: I 02A. New ST-segment depression =0.1 mV (=1 mm), or transient (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Cardiovascular E 06. Revascularization procedure already performed for the qualifying event. E 07. Acute ST-segment elevation MI Related to prior or concomitant treatments E 08. Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization. E 09. Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing E 10. Patients who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling Exclusion criteria related to the active comparator and/or mandatory background therapies Related to eptifibatide E 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. Related to unfractionated heparin E 12. Patient who cannot be treated with unfractionated heparin according to the national labeling Related to otamixaban E 13. Allergy to otamixaban
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superior efficacy (composite of all-cause death + Myocardial infarction) of otamixaban to unfractionated heparin (UFH) + eptifibatide.;Secondary Objective: • To demonstrate the superior efficacy ( composite of all-cause death + Myocardial infarction+ 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 mortality) 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 PCI as compared to UFH + eptifibatide ;Primary end point(s): Adjudicated composite of all-cause death and new myocardial infarction (MI) from randomization (Day 1) to Day 7. This endpoint will be analyzed from randomization (Day 1) to Day 30 as a sensitivity analysis. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed