drugset / Trial / NCT00169819

EArly Discharge After Transradial Stenting of CoronarY Arteries: The EASY Study

NCT00169819

RandomizedParallel-groupOpen-labelTreatment

Summary

HYPOTHESES * Discharge on the same day after uncomplicated trans-radial coronary artery stenting is safe and effective. * Hospitalized patients can be safely returned to the referring center the same day following trans-radial coronary artery stenting. * Abciximab given as a single bolus with optimal trans-radial coronary artery stenting is as safe and effective as bolus + 12 hrs perfusion and does not hamper early discharge. * Same-day discharge is cost-effective and increases patient satisfaction. OBJECTIVES AND END-POINTS The objectives of the present study are to assess the effectiveness and safety of same day hospital discharge after uncomplicated coronary artery stenting when a single bolus of Abciximab is used. The primary end-point of the study is the composite of death, myocardial infarction, repeat hospitalization, urgent revascularization, severe thrombocytopenia, access site complications and major bleedings at 30 days following stent implantation. The secondary end-point is the composite of death, myocardial infarction, repeat target vessel revascularization at 30 days, 6 months and 1 year following stent implantation. Other secondary end-points include the total hospital stay (days) between the index procedure and the first 30 days follow-up, the number of unsolicited medical visits in relation with the percutaneous procedure, index of patient satisfaction and direct and indirect costs.

Timeline

Start
2003-10
Primary completion
Completion
2006-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Abciximab Monoclonal antibody