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Myocardial Infarction With ST-Elevation (MISTRAL)
This study is currently recruiting participants.
Study NCT00638638   Information provided by University Hospital, Strasbourg, France
First Received: February 28, 2008   Last Updated: December 29, 2008   History of Changes
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February 28, 2008
December 29, 2008
January 2005
ST segment regression 1 hour after angioplasty [ Time Frame: 1 hour after angioplasty ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00638638 on ClinicalTrials.gov Archive Site
Major cardiac events at 1 and 6 month [ Time Frame: 1 and 6 month ] [ Designated as safety issue: No ]
Same as current
 
Myocardial Infarction With ST-Elevation
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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Myocardial Infarction
  • Drug: Abciximab
  • Drug: Abciximab placebo
  • 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.
  • 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
292
January 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Patrick OHLMANN, MD, PhD 33.3.88.12.88.88 Patrick.Ohlmann@chru-strasbourg.fr
France
 
 
NCT00638638
Emmanuel LAVOUE, directeur Adjoint, University Hospital, Strasbourg, France
 
University Hospital, Strasbourg, France
Eli Lilly and Company
Principal Investigator: Patrick OHLMANN, MD, PhD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
December 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.