Clinical trial NCT00638638: Myocardial Infarction With ST-Elevation
Official title: Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
Angioplasty
Coronary stenting
Abciximab
Myocardial reperfusion
Microcirculation
EKG
ST elevation myocardial infarction within 6 h of symptom onset
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2008-03-19
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: ST segment regression 1 hour after angioplasty
timeFrame: 1 hour after angioplasty
Secondary outcomes:
measure: Major cardiac events at 1 and 6 month
timeFrame: 1 and 6 month
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Patrick OHLMANN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.