Myocardial Infarction With ST-Elevation

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00638638

Acronym

MISTRAL

Enrollment

292

Registered

2008-03-19

Start date

2005-01-31

Completion date

2010-01-31

Last updated

2009-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Myocardial infarction, Angioplasty, Coronary stenting, Abciximab, Myocardial reperfusion, Microcirculation, EKG, ST elevation myocardial infarction within 6 h of symptom onset

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.

Interventions

DRUGAbciximab

* Abciximab: 0.25 mg/Kg bolus * Abciximab placebo bolus * Abciximab infusion 10 µg/Kg/min

DRUGAbciximab placebo

* Abciximab placebo Bolus * Abciximab: 0.25 mg/Kg bolus * Abciximab infusion 10 µg/Kg/min

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ST segment regression 1 hour after angioplasty	1 hour after angioplasty

Secondary

Measure	Time frame
Major cardiac events at 1 and 6 month	1 and 6 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026