MISTRAL: Myocardial Infarction With ST-Elevation

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT00638638

Collaborator

Eli Lilly and Company (Industry)

292

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: Abciximab Drug: Abciximab placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

292 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2005

Anticipated Primary Completion Date :

Aug 1, 2009

Anticipated Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Abciximab Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min Other Names: 1: Experimental 2: Experimental Drug: Abciximab placebo Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min Other Names: 1: Experimental 2: Experimental
Experimental: 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.	Drug: Abciximab Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min Other Names: 1: Experimental 2: Experimental Drug: Abciximab placebo Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min Other Names: 1: Experimental 2: Experimental

Arm

Intervention/Treatment

Experimental: 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.

Drug: Abciximab

Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min

Other Names:

1: Experimental

2: Experimental

Drug: Abciximab placebo

Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min

Other Names:

1: Experimental

2: Experimental

Experimental: 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.

Drug: Abciximab

Abciximab: 0.25 mg/Kg bolus Abciximab placebo bolus Abciximab infusion 10 µg/Kg/min

Other Names:

1: Experimental

2: Experimental

Drug: Abciximab placebo

Abciximab placebo Bolus Abciximab: 0.25 mg/Kg bolus Abciximab infusion 10 µg/Kg/min

Other Names:

1: Experimental

2: Experimental

Outcome Measures

Primary Outcome Measures

ST segment regression 1 hour after angioplasty [1 hour after angioplasty]

Secondary Outcome Measures

Major cardiac events at 1 and 6 month [1 and 6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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