Myocardial Infarction With ST-Elevation
- Registration Number
- NCT00638638
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. The lack of ST-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of Abciximab on ST-segment elevation regression at one hour after primary percutaneous angioplasty.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 292
- Patients over 18 years of age eligible for randomization in the MICU
- Infarct within 6 hours from symptoms onset
- Continuous typical chest pain symptoms symptoms for more than 20 min. and-ST segment elevation of more than 2 mm in more than two leads (peripheral or precordial)
- Signed informed consent form
- Ventricular conduction anomalies masking signs of ischemia (left or right bundle branch block without evidence of additional elevation), electrical left ventricular hypertrophy
- Known hypersensitivity to Abciximab or to any component of the product or to murine monoclonal antibodies.- Hemorrhagic diathesis, internal hemorrhage
- Hemorrhagic stroke within 2 years
- Ischemic stroke within the last 3 months- Intra-cranial neoplasm, intracranial malformation or arteria
- venous aneurysm
- Recent intracranial or intraspinal surgery or trauma (within two months)
- Recent within (2 months) major surgery- Known peptic ulcer or upper gastrointestinal bleeding within the previous 6 month
- Known coagulation anomaly
- Oral anti-coagulant or low molecular weight heparin treatment- Ongoing thrombolytic treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Abciximab * Abciximab placebo bolus during prehospital transportation in ambulance with Heparin 40 UI/kg bolus. * Abciximab 0.25 mg/Kg bolus after coronary angiography and before angioplasty followed by Abciximab infusion 10 µg/Kg/min. 1 Abciximab * Early Abciximab bolus during prehospital transportation in ambulance 0.25 mg/Kg iv with Heparin 40 UI/kg bolus. * Abciximab placebo bolus and Abciximab infusion 10 µg/Kg/min after coronary angiography and before angioplasty. 1 Abciximab placebo * Early Abciximab bolus during prehospital transportation in ambulance 0.25 mg/Kg iv with Heparin 40 UI/kg bolus. * Abciximab placebo bolus and Abciximab infusion 10 µg/Kg/min after coronary angiography and before angioplasty. 2 Abciximab placebo * Abciximab placebo bolus during prehospital transportation in ambulance with Heparin 40 UI/kg bolus. * Abciximab 0.25 mg/Kg bolus after coronary angiography and before angioplasty followed by Abciximab infusion 10 µg/Kg/min.
- Primary Outcome Measures
Name Time Method ST segment regression 1 hour after angioplasty 1 hour after angioplasty
- Secondary Outcome Measures
Name Time Method Major cardiac events at 1 and 6 month 1 and 6 month
Trial Locations
- Locations (1)
Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière
🇫🇷Strasbourg, France