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

Myocardial Infarction Clinical Trial

Official title: A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute Myocardial Infarction: The EASY-MI Pilot Study.

Status Completed

Clinical Trial 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.

Clinical Trial Description

OBJECTIVES AND END-POINTS The objectives of the present study are to assess the benefits and safety of 1) a single bolus of abciximab (100% dose) compared with the standard bolus (ca 80% of the total dose) + 12h infusion (ca 20% of the total dose), and 2) intracoronary abciximab bolus administration compared with intravenous route of abciximab administration in primary PCI.

The primary PLATELETS end-points are the percentage of patients with ≥ 95% platelet aggregation inhibition 10 minutes after abciximab bolus (MAX) and the mean platelet aggregation inhibition 10 minutes after abciximab bolus (MEAN).

The secondary CLINICAL end-points of the study are:

• The composite of death, stroke, repeat myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.

• The composite of cardiovascular death, repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up.

The secondary ANGIOGRAPHIC end-points of the study are:

• The proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.

• The restenosis rate (diameter stenosis ≥ 50%) and late loss in the culprit vessel at 6-months follow-up.

Other exploratory end-points are the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, the cardiac MRI measurements and platelet aggregation inhibition at 6h post-PCI. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Ischemia
• Myocardial Infarction

• NCT number: NCT00440778
• Study type: Interventional
• Source: Laval University
• Status: Completed
• Phase: Phase 4
• Start date: February 2007
• Completion date: October 2008