Efficacy of Abciximab Bolus Only Regimen in Providing Inhibition of Platelet Action Over Time

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 aggregation after 4 hours as measured by LTA (20micromol ADP) when compared with abciximab plus infusion and 300 mg clopidogrel loading dose.

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

Details

• Lead Sponsor: Università degli Studi di Ferrara
• Treatments: Abciximab; Antibodies, Monoclonal; Clopidogrel; Immunoglobulin Fab Fragments; Ticlopidine

Criteria

Inclusion Criteria:

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 Criteria:

• 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.