Coronary desease in patients with non-ST elevation acute coronary syndrome and planned early invasive strategy MedDRA version: 8.1 Level: LLT Classification code 10051592
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
Other descriptive name:
Sponsors
Sanofi aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or non pregnant female = 18 years old (or = country’s legal age of majority) • Ischemic discomfort (i.e. ischemic chest pain or equivalent) at rest = 10 min within 24 hours of randomization • Patient meets one of the two following criteria of non-ST elevation ACS : - 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: General 1. Treatment with other investigational agents or devices within 30 days prior to randomization, or planned use of investigational agents or devices prior to the Day 30 visit 2. Inability to give informed consent, or high likelihood of being unavailable for the Day 180 follow 3. Breastfeeding 4. Pregnancy, as evidenced by a positive urine pregnancy test performed prior to randomization 5. Known creatinine clearance 180 Kg 7. Any other condition, which, in the opinion of the Investigator may pose a significant hazard to the patients if he or she is enrolled in the trial Cardiovascular 1. Anticipated inability to undergo a coronary angiography, and, if indicated PCI, by Day 3 2. Prior recent PCI performed within 30 days prior to randomization 3. Acute ST-segment elevation MI requiring immediate thrombolytic or primary PCI 4. Cardiogenic shock(SBP 200 mmHg, or DBP > 110 mmHg) not adequately controlled on antihypertensive therapy 5. Recent (< 6 weeks) trauma, or major surgery, including CABG 6. History of stroke within 30 days or any history of hemorrhagic stroke 7. Known history of intracranial disease 8. Current or planned administration of another GP IIb/IIIa inhibitor 9. Known thrombocytopenia (< 100,000/µl) at randomization 10. Known International Normalized Ratio (INR) = 2 Related to clopidogrel 1. Known allergy to clopidogrel 2. Treatment with daily clopidogrel cannot be initiated at the time of randomization Related to aspirin 1. Known allergy to aspirin 2. Treatment with daily aspirin cannot be initiated at the time of randomization Related to unfractionated heparin 1. History of heparin-induced thrombocytopenia syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the clinical efficacy of otamixaban via an evaluation of the dose effect ( 5 IV regimens ) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy i.e. scheduled to undergo an early (= Day 3) diagnostic catheterization followed, when indicated, by a percutaneous coronary intervention (PCI).;Secondary Objective: • To evaluate the net clinical benefit of the various otamixaban regimens, in comparison to UFH plus eptifibatide • To evaluate the safety of otamixaban • To asses the effects of otamixaban on : - post-PCI cardiac markers - coagulation tests (PK-PD sites) - markers of activation of coagulation (PK-PD sites) - markers of inflammation (PK-PD sites) - von Willebrand factor (PK-PD sites) • To assess the otamixaban plasma concentrations (PK-PD sites);Primary end point(s): Quadruple efficacy composite of all-cause death, new myocardial infarction (MI), severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of GPIIb/IIIa inhibitor within 7 days following randomization | — |
Countries
Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Portugal, Slovakia
Outcome results
None listed