EArly Discharge After Transradial Stenting of CoronarY Arteries: The EASY Study
Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Laval University
Collaborators:
Bristol-Myers Squibb Eli Lilly and Company
Treatments:
Abciximab Antibodies, Monoclonal Immunoglobulin Fab Fragments