Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169819
Status:
COMPLETED
Last Update Posted:
2007-02-26
First Post:
2005-09-09
Brief Title:
EArly Discharge After Transradial Stenting of CoronarY Arteries The EASY Study
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
A Randomized Trial Comparing Same Day Discharge and a Single Bolus of Abciximab to Overnight Hospitalization and Bolus Perfusion Abciximab After Uncomplicated Trans-Radial Coronary Artery Stenting
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Despite significant improvements in clinical results associated with the current use of stenting and pharmacologic agents there has been little modification in hospitalization duration after percutaneous coronary interventions PCI The main reasons associated with prolonged hospitalization after PCI remain 1 the fear of abrupt vessel closure and its associated morbidity 2 the need for prolonged bed rest in case of femoral approach even after use of device closures
The introduction of coronary stents has been associated with a dramatic decrease in vessel closure once it was recognized that stent deployment required higher pressure balloon inflation and increased antiplatelet therapy Trans-radial coronary interventions appear safer and more cost-effective than femoral PCI However the current use of IIb-IIIa inhibitors prohibits the early discharge of patients following PCI because their pharmacology generally imposes to pursue drug infusion between 18 and 24 hrs following PCI which does not allow same day discharge from the hospital With Abciximab however pharmacologic data indicate that prolonged platelet inhibition 80 occurs after a single bolus Based on the EPIC trial results it has been recommended to prolong platelet inhibition by a 12 hrs perfusion By analyzing carefully the EPIC trial results we hypothesized that after optimal stenting result a single bolus of Abciximab would suffice We aim to demonstrate that 1 with trans-radial coronary stenting at least 50 of the entire population referred for PCI could be safely discharged after a few hours observation 2 a single bolus of Abciximab is at least as effective as current recommended treatment with a bolus 12 hrs perfusion after uncomplicated stenting This new regimen could significantly affect current practice decrease hospital costs and increase patient satisfaction after PCI
STUDY DESIGN
A prospective randomized single-center study comparing same day hospital discharge to overnight hospitalization after uncomplicated trans-radial coronary artery stenting Out-patients will be randomized after successful stent implantation to same day discharge or will remain hospitalized at Laval Hospital until the next morning Hospitalized patients will be randomized after successful stent implantation to either same day discharge at home or to overnight hospitalization either at the referring center or at Laval Hospital All eligible patients will be treated with Abciximab that will be administered according to 2 different arms For patients randomized to same-day discharge only a bolus of Abciximab will be given whereas for all remaining patients Abciximab will be given according to current practice ie bolus 12 hrs perfusion All patients which will not be eligible post-PCI will enter a registry
The introduction of coronary stents has been associated with a dramatic decrease in vessel closure once it was recognized that stent deployment required higher pressure balloon inflation and increased antiplatelet therapy Trans-radial coronary interventions appear safer and more cost-effective than femoral PCI However the current use of IIb-IIIa inhibitors prohibits the early discharge of patients following PCI because their pharmacology generally imposes to pursue drug infusion between 18 and 24 hrs following PCI which does not allow same day discharge from the hospital With Abciximab however pharmacologic data indicate that prolonged platelet inhibition 80 occurs after a single bolus Based on the EPIC trial results it has been recommended to prolong platelet inhibition by a 12 hrs perfusion By analyzing carefully the EPIC trial results we hypothesized that after optimal stenting result a single bolus of Abciximab would suffice We aim to demonstrate that 1 with trans-radial coronary stenting at least 50 of the entire population referred for PCI could be safely discharged after a few hours observation 2 a single bolus of Abciximab is at least as effective as current recommended treatment with a bolus 12 hrs perfusion after uncomplicated stenting This new regimen could significantly affect current practice decrease hospital costs and increase patient satisfaction after PCI
STUDY DESIGN
A prospective randomized single-center study comparing same day hospital discharge to overnight hospitalization after uncomplicated trans-radial coronary artery stenting Out-patients will be randomized after successful stent implantation to same day discharge or will remain hospitalized at Laval Hospital until the next morning Hospitalized patients will be randomized after successful stent implantation to either same day discharge at home or to overnight hospitalization either at the referring center or at Laval Hospital All eligible patients will be treated with Abciximab that will be administered according to 2 different arms For patients randomized to same-day discharge only a bolus of Abciximab will be given whereas for all remaining patients Abciximab will be given according to current practice ie bolus 12 hrs perfusion All patients which will not be eligible post-PCI will enter a registry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN72335887 | None | None | None |