Myocardial Infarction With ST-Elevation

NCT00638638 | Unknown Phase 3

• 1 other identifier: 3233
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• ST segment regression 1 hour after angioplasty

  1 hour after angioplasty

Secondary Outcomes (1)

• Major cardiac events at 1 and 6 month

  1 and 6 month

Study Arms (2)

1

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.

Drug: Abciximab; Drug: Abciximab placebo

2

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.

Drug: Abciximab; Drug: Abciximab placebo

Interventions

Abciximab DRUG

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

Also known as: 1: Experimental, 2: Experimental

1; 2

Abciximab placebo DRUG

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

Also known as: 1: Experimental, 2: Experimental

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière

Strasbourg, 67 098, France

Location

Related Publications (1)

• 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.

  PMID: 22319064 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Patrick OHLMANN, MD, PhD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 19, 2008
• Study Start: January 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: January 1, 2010
• Last Updated: September 17, 2009

Record last verified: 2009-09

Locations

FR (1)