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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

HYPOTHESES

1. Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.

2. Total dose of abciximab can be given as a single bolus and is more effective than bolus (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical results.

3. Intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results.

4. There is a relationship between PAI and angiographic perfusion scores.

5. Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated with a low rate of target vessel revascularization and complications.

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

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

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

Details

• Lead Sponsor: Laval University
• Collaborators: Cordis Corporation; Eli Lilly and Company; Quebec Heart Institute
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

• Patient with acute myocardial infarction eligible for primary PCI within 6 h of symptoms: patient must have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset within 6 h of randomization, and one of the following:

• ST-segment elevation ≥ 2 mm in 2 or more contiguous precordial ECG leads (anterior infarction)

• ST-segment depression ≥ 2 mm in V1, V2 or V2, V3 with reciprocal 1 mm ST-elevation in II, augmented unipolar foot (left leg) lead (AVF), and V6 (true posterior infarction)

• ST-segment elevation ≥ 1 mm in 2 or more contiguous limb ECG leads (other infarction)

• New or presumably new left bundle branch block (LBBB)

• Patient must be > 18 years of age.

• 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 trans-radial/ulnar artery approach.

• The culprit lesion can be identified on a native coronary vessel, which is suitable for primary PCI with stent implantation.

Exclusion Criteria:

• Patient has received thrombolytic therapy (within the last 4 weeks) and is referred for rescue PCI

• Concurrent participation in other investigational study

• Femoral sheath (artery)

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

• Any significant blood dyscrasia, diathesis or INR > 2.0

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

• Any glycoprotein IIb-IIIa inhibitors use in the previous 30 days

• 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

• Infarction caused by in-stent thrombosis or restenosis

• Cardiogenic shock evident before randomization