Myocardial Infarction With ST-Elevation

NCT ID: NCT00638638

Last Updated: 2009-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2010-01-31

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Abciximab

Intervention Type: DRUG

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

Abciximab placebo

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Abciximab

Intervention Type: DRUG

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

Abciximab placebo

Intervention Type: DRUG

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

Interventions

Abciximab

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

Intervention Type: DRUG

Abciximab placebo

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

Intervention Type: DRUG

Other Intervention Names

1: Experimental; 2: Experimental; 1: Experimental; 2: Experimental

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

University Hospital, Strasbourg, France

Principal Investigators

Patrick OHLMANN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière

Strasbourg, , France

Countries

France

References

Ohlmann P, Reydel P, Jacquemin L, Adnet F, Wolf O, Bartier JC, Weiss A, Lapostolle F, Gaultier C, Salengro E, Benamer H, Guyon P, Chevalier B, Catan S, Ecollan P, Chouihed T, Angioi M, Zupan M, Bronner F, Bareiss P, Steg G, Montalescot G, Monassier JP, Morel O. Prehospital abciximab in ST-segment elevation myocardial infarction: results of the randomized, double-blind MISTRAL study. Circ Cardiovasc Interv. 2012 Feb 1;5(1):69-76, S1. doi: 10.1161/CIRCINTERVENTIONS.111.961425. Epub 2012 Feb 7.

Reference Type: DERIVED

PMID: 22319064 (View on PubMed)

Other Identifiers

3233

Identifier Type: -

Identifier Source: org_study_id