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

NCT00169819 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2007-02-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Abciximab

Sponsors & Collaborators

Principal Investigators

  • Olivier F Bertrand, MD, PhD · Laval Hospital Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Completion
2006-04-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00169819 on ClinicalTrials.gov