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
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: Abciximab
Drug: Abciximab placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • ST segment regression 1 hour after angioplasty [ Time Frame: 1 hour after angioplasty ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major cardiac events at 1 and 6 month [ Time Frame: 1 and 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 292
Study Start Date: January 2005
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638638

Locations
France
Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière
Strasbourg, France, 67 098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Eli Lilly and Company
Investigators
Principal Investigator: Patrick OHLMANN, MD, PhD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided by University Hospital, Strasbourg, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christine GEILLER, directeur Adjoint, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00638638     History of Changes
Other Study ID Numbers: 3233
Study First Received: February 28, 2008
Last Updated: September 16, 2009
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Myocardial infarction
Angioplasty
Coronary stenting
Abciximab
Myocardial reperfusion
Microcirculation
EKG
ST elevation myocardial infarction within 6 h of symptom onset

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014