None listed
Conditions
Interventions
Group 1 Type of group
Otamixaban: Bolus IV of 0.080 mg / kg
Group 2 Type of group
UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first. Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with Acute Coronary Syndrome without STE segment elevation • Patients in whom coronary angiography is planned (followed by PCI, when indicated) as soon as possible (after at least 2 hours of treatment with the study medication) and within 36 hours (no later than Day 3 , if justified) • Informed consent obtained in writing
Exclusion criteria
Exclusion criteria: • High probability of not being available for follow-up on Day 180 • Age <18 years (or legal age in the country) • Pregnancy, demonstrated by a positive urine pregnancy test, performed before randomization (applicable only to women with the potential to conceive, that is, premenopausal or postmenopausal women for <2 years) • Treatment with other investigating agents (including placebo) or devices within 30 days prior to randomization, or planned use of investigating agents or devices during the study • Breastfeeding • A revascularization procedure has already been performed for the qualifying event. • Acute MI with ST segment elevation • Patients who have received a curative dose of an anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours before randomization. • Inability to suspend the current anticoagulation to make the transition to Research Products according to the time specified for the transition. • Patients who cannot be treated with acetylsalicylic acid and clopidogrel (or with any other oral antiplatelet agent) according to their local product information. • Patients who cannot be treated with eptifibatide according to the national product information (when available). In countries where eptifibatide is not approved, the reference product information to be considered will be the European product information or the product information in the USA (see Appendix H and Appendix I). • Patients who cannot be treated with unfractionated heparin according to national product information • Allergy to otamixaban
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Deaths, myocardial infarction / episodes of myocardial ischemia, the use of rescue GPIIb / IIIa, thrombotic and non-thrombotic complications of the procedure, and any cerebral vascular events on the specific pages of the e-CRF will be reported. Measure:Compound awarded with death from all causes and new myocardial infarction (MI) from random assignment (Day 1) to Day 7. Timepoints:from random assignment (Day 1) to Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The MI will be evaluated from randomisation, according to the ACC criteria [25] until Day 180 or 30 days after the last patient has been randomized, whichever comes first. To meet the criteria for the MI of the valuation criteria, the MI must be different from the reference event. Cerebral vascular events will be reported on the specific pages of the e-CRF. Measure:Triple compound of efficacy, death from all causes, new myocardial infarction and any cerebral vascular event from randomisation (Day 1) to Day 7 Timepoints:from randomisation (Day 1) to Day 7 ; Outcome name:Among the episodes of myocardial ischemia, only myocardial infarctions or myocardial ischemia episodes leading to rehospitalization or, if the patient is in the hospital, those leading to a change in patient management will be reported and adjudicated ( change in treatment, need to perform an ECG or additional cardiac marker tests, or need to perform an angiogram). Measure:Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia / myocardial infarction from randomisation (Day 1) to Day 30 Timepoints:from randomisation (Day 1) to Day 30 ; Outcome name:All deaths from all causes will be recorded during the study. Measure:Death due to all causes awarded from random assignment (Day 1) to Day 30 Timepoints:from random assignment (Day 1) to Day 30 | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Greece, Hungaria, Italy, Latovia, Lithuania, Netherlands, Peru, Portugal, Spain, United Kindgdom
Contacts
Public ContactShellah Albites
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed