Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440895
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2007-02-23
Brief Title:
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI and Rescue-PCI
Sponsor:
Olivier F Bertrand
Organization:
Laval University
Study Overview
Official Title:
A Randomized Trial of Early Discharge After Trans-Radial Stenting of Coronary Arteries in Acute Myocardial Infarction and RESCUE-PCI The EASY-RESCUE Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-05
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:
EASY-RESCUE
Brief Summary:
Abciximab administration is safe and reduces ischemic complications in patients undergoing rescue PCI after failed thrombolysis compared to placebo
Abciximab improves angiographic scores and ventricular function after rescue-PCI compared to placebo
Intracoronary abciximab administration is more effective than intravenous route of administration in terms of acute and mid-term angiographic and clinical results
Intracoronary and intravenous bolus administration of abciximab dose provides similar platelet aggregation inhibition PAI
There is a significant relationship between PAI after abciximab administration and indexes of myocardial perfusion
Routine use of Sirolimus-eluting stents Cypher Cordis US in rescue-PCI is associated with a low rate of target vessel revascularization
Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial injury and irreversible necrosis which are correlated with angiographic perfusion scores
After uncomplicated trans-radial rescue PCI patients can be retransferred early to their referring center
Abciximab improves angiographic scores and ventricular function after rescue-PCI compared to placebo
Intracoronary abciximab administration is more effective than intravenous route of administration in terms of acute and mid-term angiographic and clinical results
Intracoronary and intravenous bolus administration of abciximab dose provides similar platelet aggregation inhibition PAI
There is a significant relationship between PAI after abciximab administration and indexes of myocardial perfusion
Routine use of Sirolimus-eluting stents Cypher Cordis US in rescue-PCI is associated with a low rate of target vessel revascularization
Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial injury and irreversible necrosis which are correlated with angiographic perfusion scores
After uncomplicated trans-radial rescue PCI patients can be retransferred early to their referring center
Detailed Description:
OBJECTIVES AND END-POINTS
The objectives of the present pilot study are to assess 1 the benefits and safety of abciximab ic or iv compared to placebo in rescue PCI and trans-radial approach 2 the relationship between platelet aggregation inhibition and perfusion scores and to demonstrate 3 better perfusion scores with ic abciximab as compared to iv abciximab or placebo
The Primary ANGIOGRAPHIC end-point will be the TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-months follow-up
The Secondary CLINICAL end-point will be
the composite of death stroke repeat-myocardial infarction urgent target vessel revascularization and major bleedings at 30 days after rescue PCI
composite of death repeat-myocardial infarction repeat target vessel revascularization at 6 months following rescue PCI
The Secondary PLATELETS end-point will be the proportion of patients with platelet aggregation inhibition 95 and mean platelet aggregation inhibition 10 minutes post-bolus administration
The Secondary ANGIOGRAPHIC end-points will be the angiographic late loss and the restenosis rate Diameter stenosis 50 in the culprit artery
Other exploratory end-points include the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI cardiac MRI measurements and PAI 6 hr after bolus administration
The objectives of the present pilot study are to assess 1 the benefits and safety of abciximab ic or iv compared to placebo in rescue PCI and trans-radial approach 2 the relationship between platelet aggregation inhibition and perfusion scores and to demonstrate 3 better perfusion scores with ic abciximab as compared to iv abciximab or placebo
The Primary ANGIOGRAPHIC end-point will be the TIMI score and myocardial blush grade after rescue-PCI at baseline and at 6-months follow-up
The Secondary CLINICAL end-point will be
the composite of death stroke repeat-myocardial infarction urgent target vessel revascularization and major bleedings at 30 days after rescue PCI
composite of death repeat-myocardial infarction repeat target vessel revascularization at 6 months following rescue PCI
The Secondary PLATELETS end-point will be the proportion of patients with platelet aggregation inhibition 95 and mean platelet aggregation inhibition 10 minutes post-bolus administration
The Secondary ANGIOGRAPHIC end-points will be the angiographic late loss and the restenosis rate Diameter stenosis 50 in the culprit artery
Other exploratory end-points include the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI cardiac MRI measurements and PAI 6 hr after bolus administration
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