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Myocardial Infarction With ST-Elevation (MISTRAL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00638638
First received: February 28, 2008
Last updated: September 16, 2009
Last verified: September 2009

February 28, 2008
September 16, 2009
January 2005
August 2009   (final data collection date for primary outcome measure)
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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Myocardial Infarction
  • 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: 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.
    Interventions:
    • Drug: Abciximab
    • Drug: Abciximab placebo
  • 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.
    Interventions:
    • Drug: Abciximab
    • Drug: Abciximab placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not 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 information is only displayed when the study is recruiting subjects
France
 
NCT00638638
3233
No
Christine GEILLER, 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
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP