Myocardial Infarction With ST-Elevation
This trial is active, not recruiting.
|Treatments||abciximab, abciximab placebo|
|Sponsor||University Hospital, Strasbourg, France|
|Collaborator||Eli Lilly and Company|
|Start date||January 2005|
|End date||August 2009|
|Trial size||292 participants|
|Trial identifier||NCT00638638, 3233|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
ST segment regression 1 hour after angioplasty
time frame: 1 hour after angioplasty
Major cardiac events at 1 and 6 month
time frame: 1 and 6 month
Male or female participants at least 18 years old.
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
|Official title||Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.|
|Principal investigator||Patrick OHLMANN, MD, PhD|
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