Overview

This trial is active, not recruiting.

Condition myocardial infarction
Treatments abciximab, abciximab placebo
Phase phase 3
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
abciximab 1: Experimental
Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min
abciximab placebo 1: Experimental
Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min
(Experimental)
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.
abciximab 1: Experimental
Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min
abciximab placebo 1: Experimental
Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min

Primary Outcomes

Measure
ST segment regression 1 hour after angioplasty
time frame: 1 hour after angioplasty

Secondary Outcomes

Measure
Major cardiac events at 1 and 6 month
time frame: 1 and 6 month

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by University Hospital, Strasbourg, France.