Myocardial Infarction With ST-Elevation

Myocardial Infarction Clinical Trial

— MISTRAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00638638
• Other study ID #: 3233
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 28, 2008
• Last updated: September 16, 2009
• Start date: January 2005
• Est. completion date: January 2010

Study information

• Verified date: September 2009
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 292
• Est. completion date: January 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
France	Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	Eli Lilly and Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ST segment regression 1 hour after angioplasty		1 hour after angioplasty	No
Secondary	Major cardiac events at 1 and 6 month		1 and 6 month	No