Myocardial Infarction With ST-Elevation (MISTRAL)

September 16, 2009 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

292

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67 098
        • Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ST segment regression 1 hour after angioplasty
Time Frame: 1 hour after angioplasty
1 hour after angioplasty

Secondary Outcome Measures

Outcome Measure
Time Frame
Major cardiac events at 1 and 6 month
Time Frame: 1 and 6 month
1 and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Patrick OHLMANN, MD, PhD, Hôpitaux Universitaires de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2009

Last Update Submitted That Met QC Criteria

September 16, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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