NCT00440778

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myocardial Infarction
• Ischemia

Interventions

Type	Name	Description
DRUG	Abciximab	100% abciximab bolus dose (0.3 mg/kg) ic or iv vs standard bolus (0.25 mg/kg) ic or iv plus 12-hr infusion

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-02-27
• Last updated: 2011-11-24

Locations

1 site across 1 country: Canada