Myocardial Infarction With ST-Elevation

Study Overview
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Brief Summary
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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.

Official Title
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Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Abciximab
* Drug: Abciximab placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: Abciximab<br>* Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min<br>* Other names: 2: Experimental;Drug: Abciximab placebo<br>* Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min<br>* Other names: 2: Experimental;|
| Experimental: 2<br>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. | Drug: Abciximab<br>* Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min<br>* Other names: 2: Experimental;Drug: Abciximab placebo<br>* Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min<br>* Other names: 2: Experimental;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST segment regression 1 hour after angioplasty |  | 1 hour after angioplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac events at 1 and 6 month |  | 1 and 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Angioplasty, Coronary stenting, Abciximab, Myocardial reperfusion, Microcirculation, EKG, ST elevation myocardial infarction within 6 h of symptom onset