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ClinicalTrials.gov Identifier: NCT00638638
Verified September 2009 by University Hospital, Strasbourg, France. Recruitment status was: Active, not recruiting
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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