Myocardial Infarction With ST-Elevation - Full Text View

Sponsors and Collaborators:	University Hospital, Strasbourg, France Eli Lilly and Company
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00638638

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Myocardial Infarction With ST-Elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

Drug Information available for: Abciximab

U.S. FDA Resources

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

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

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

Contacts

Contact: Patrick OHLMANN, MD, PhD

33.3.88.12.88.88

Patrick.Ohlmann@chru-strasbourg.fr

Locations

France
Service de Cardiologie - Hôpital de Hautepierre - 1, Avenue Molière	Recruiting
Strasbourg, France, 67 098
Contact: Patrick OHLMANN, MD, PhD 33.3.88.12.88.88 Patrick.Ohlmann@chru-strasbourg.fr

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

Responsible Party:	University Hospital, Strasbourg, France ( Emmanuel LAVOUE, directeur Adjoint )
Study ID Numbers:	3233
Study First Received:	February 28, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00638638 History of Changes
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

Study placed in the following topic categories:

Necrosis
Anticoagulants
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Abciximab
Platelet Aggregation Inhibitors
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Anticoagulants
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Abciximab
Ischemia
Pharmacologic Actions

Necrosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 10, 2009