A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI and Rescue-PCI

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

• Abciximab administration is safe and reduces ischemic complications in patients undergoing rescue PCI after failed thrombolysis compared to placebo.

• Abciximab improves angiographic scores and ventricular function after rescue-PCI compared to placebo.

• Intracoronary abciximab administration is more effective than intravenous route of administration in terms of acute and mid-term angiographic and clinical results.

• Intracoronary and intravenous bolus administration of abciximab dose provides similar platelet aggregation inhibition (PAI).

• There is a significant relationship between PAI after abciximab administration and indexes of myocardial perfusion.

• Routine use of Sirolimus-eluting stents (Cypher, Cordis, US) in rescue-PCI is associated with a low rate of target vessel revascularization.

• Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.

• After uncomplicated trans-radial rescue PCI, patients can be retransferred early to their referring center.

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

Details

• Lead Sponsor: Olivier F. Bertrand
• Collaborators: Cordis Corporation; Eli Lilly and Company
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

• Patient with acute myocardial infarction eligible for rescue PCI within 24 hrs of symptoms.

• Failed thrombolysis (defined as less than 50% reduction of ST-elevation at 90 min ECG in the lead with previous maximal ST-segment elevation).

• Patient > 18 years old.

• Patient and treating interventional cardiologist agree for randomization.

• Patient will be informed of the randomization process and will sign an informed consent.

• Diagnostic and therapeutic intervention performed through transradial/transulnar approach.

• The culprit lesion in a native coronary artery can identified and is suitable for immediate angioplasty and stent implantation.

Exclusion Criteria:

• Age > 75 years old

• Body weight < 65 kg

• Concurrent participation in other investigational study

• Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months

• Any significant blood dyscrasia, diathesis or INR > 2.0.

• Any clinical contraindication to abciximab administration i.e. known structural intracranial lesion, thrombocytopenia (< 100,000), hemoglobin level < 10 g/dl

• Patient has received more than one dose of thrombolytic within 24 hours of symptoms

• Previous treatment with glycoproteins IIb-IIIa inhibitors within 30 days

• Perceived increased risk of intracranial or severe bleeding i.e. previous stroke/TIA, alteration of consciousness, recent trauma or major surgery.

• Uncontrolled high blood pressure i.e. systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg.

• Life expectancy less than 6 months owing to non-cardiac cause

• Evident cardiogenic shock