Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.
Overview
- Phase
- Phase 3
- Intervention
- Abciximab
- Conditions
- Myocardial Infarction
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 292
- Locations
- 1
- Primary Endpoint
- ST segment regression 1 hour after angioplasty
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1
* 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.
Intervention: Abciximab
1
* 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.
Intervention: Abciximab placebo
2
* 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.
Intervention: Abciximab
2
* 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.
Intervention: Abciximab placebo
Outcomes
Primary Outcomes
ST segment regression 1 hour after angioplasty
Time Frame: 1 hour after angioplasty
Secondary Outcomes
- Major cardiac events at 1 and 6 month(1 and 6 month)