Efficacy Study on Early Versus Late Abciximab Administration During Primary Coronary Angioplasty

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Abciximab has been demonstrated to improve outcome when administered during primary angioplasty in patients with acute myocardial infarction. The Primary Objective of the study is to demonstrate that early (before transportation form remote hospital to the cath lab) abciximab administration during acute myocardial infarction reduces infarct size as compared with late (just prior to PCI) abciximab administration, as measured by delayed enhancement magnetic resonance (MR) at 6 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pisa
• Collaborator: Eli Lilly and Company
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

• Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 6 hours prior to randomization, and ST segment elevation ≥ 2mm or new left bundle branch block

• Absence of contraindications to Abciximab (for details cf. below section)

• Written informed consent

Exclusion Criteria:

• Low-risk (ST elevation in ≤2 leads) inferior AMI

• Previous infarction in the same area (assessed by ECG)

• PCI in the 2 weeks prior to AMI

• Know hypersensitivity to abciximab

• Active internal bleeding

• History of cerebrovascular accident in the previous 2 years or cerebrovascular accident with a significant residual neurological deficit

• Head or spine surgery or trauma in the previous 2 months

• Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance

• Administration of oral anticoagulants within seven days unless prothrombin time is <1.2 times control

• Bleeding diathesis or severe uncontrolled arterial hypertension

• Thrombocytopenia (<100 000 cells/mL)

• Recent (within six weeks) major surgery or trauma

• Intracranial neoplasm, arteriovenous malformation, or aneurysm

• Severe renal or liver failure

• Allergy to aspirin

• Contraindication to MRI examination