Status:
COMPLETED
Efficacy of Abciximab Bolus Only Regimen in Providing Inhibition of Platelet Action Over Time
Lead Sponsor:
Università degli Studi di Ferrara
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In full responders to clopidogrel scheduled to undergo PCI for NSTEACS, the use of abciximab bolus only plus 600 mg clopidogrel loading dose will result in a non-inferior inhibition of platelet aggreg...
Detailed Description
Based on the outcome of the EPIC trial, and the sub-optimal results with a single abciximab bolus compared with bolus and infusion, it was recommended to prolong platelet inhibition by a 12h infusion ...
Eligibility Criteria
Inclusion
- Both of the following:
- Age \>18 years
- Symptoms of ischemia that were increasing or occurred at rest, with the last episode occurring no more than 24 hours before randomization;
- AND at least one of the following:
- An elevated cardiac troponin T level (≥0.015 μg per liter);
- The presence of ischemic changes as assessed by electrocardiography (defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV, or T-wave inversion of ≥0.2 mV in two contiguous leads)
- A documented history of coronary artery disease as evidenced by previous myocardial infarction, findings on previous coronary angiography, or a positive exercise test.
Exclusion
- The exclusion criteria are:
- administration of fibrinolytic or any GP IIb IIIa inhibitors for the treatment of current AMI or within 1 month before it
- history of bleeding diathesis
- known sensitivity to abciximab, to any component of the product or to murine monoclonal antibodies
- major surgery or trauma within 30 days
- active bleeding
- previous stroke in the last six months
- oral anticoagulant therapy
- pre-existing thrombocytopenia;
- vasculitis;
- hypertensive retinopathy;
- severe hepatic failure,
- severe renal failure requiring haemodialysis
- documented allergy/intolerance or contraindication to clopidogrel or inability to assume clopidogrel on a consecutive daily basis for a minimum of 30 days, or to heparin or aspirin
- uncontrolled hypertension (systolic or diastolic arterial pressure \>180 mmHg or 120, respectively, despite medical therapy)
- limited life expectancy, e.g. neoplasms, others
- inability to obtain informed consent
- pregnancy.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00929279
Start Date
November 1 2008
End Date
May 1 2009
Last Update
June 29 2009
Active Locations (1)
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1
Institue of Cardiology, University of Ferrara
Ferrara, Ferrara, Italy, 44100