Status:
COMPLETED
Efficacy Study on Early Versus Late Abciximab Administration During Primary Coronary Angioplasty
Lead Sponsor:
University of Pisa
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Strategies directed at improving myocardial perfusion or viability in the setting of acute myocardial infarction (AMI) are currently suboptimal. The consequences of microvascular damage, as assessed b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00354406
Start Date
April 1 2006
End Date
December 1 2008
Last Update
November 16 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiothoracic Department, Ospedale Cisanello
Pisa, Italy, 56124