Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440778
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2007-02-23
Brief Title:
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute Myocardial Infarction The EASY-MI Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-11
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-MI
Brief Summary:
HYPOTHESES
1 Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition PAI compared with standard bolus 025 mgkg administration
2 Total dose of abciximab can be given as a single bolus and is more effective than bolus 025 mgkg 12 hrs infusion in terms of acute and mid-term angiographic and clinical results
3 Intracoronary ic abciximab administration is more effective than intravenous iv route of administration in terms of acute and mid-term angiographic and clinical results
4 There is a relationship between PAI and angiographic perfusion scores
5 Routine use of sirolimus-eluting stents Cypher Cordis in primary-PCI is associated with a low rate of target vessel revascularization and complications
6 Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis which are correlated with angiographic perfusion scores
7 After uncomplicated trans-radial PCI patients can be retransferred early to their referring center
1 Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition PAI compared with standard bolus 025 mgkg administration
2 Total dose of abciximab can be given as a single bolus and is more effective than bolus 025 mgkg 12 hrs infusion in terms of acute and mid-term angiographic and clinical results
3 Intracoronary ic abciximab administration is more effective than intravenous iv route of administration in terms of acute and mid-term angiographic and clinical results
4 There is a relationship between PAI and angiographic perfusion scores
5 Routine use of sirolimus-eluting stents Cypher Cordis in primary-PCI is associated with a low rate of target vessel revascularization and complications
6 Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis which are correlated with angiographic perfusion scores
7 After uncomplicated trans-radial PCI patients can be retransferred early to their referring center
Detailed Description:
OBJECTIVES AND END-POINTS The objectives of the present study are to assess the benefits and safety of 1 a single bolus of abciximab 100 dose compared with the standard bolus ca 80 of the total dose 12h infusion ca 20 of the total dose and 2 intracoronary abciximab bolus administration compared with intravenous route of abciximab administration in primary PCI
The primary PLATELETS end-points are the percentage of patients with 95 platelet aggregation inhibition 10 minutes after abciximab bolus MAX and the mean platelet aggregation inhibition 10 minutes after abciximab bolus MEAN
The secondary CLINICAL end-points of the study are
The composite of death stroke repeat myocardial infarction urgent target vessel revascularization and major bleedings at 30 days following primary PCI
The composite of cardiovascular death repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up
The secondary ANGIOGRAPHIC end-points of the study are
The proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel
The restenosis rate diameter stenosis 50 and late loss in the culprit vessel at 6-months follow-up
Other exploratory end-points are the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI the cardiac MRI measurements and platelet aggregation inhibition at 6h post-PCI
The primary PLATELETS end-points are the percentage of patients with 95 platelet aggregation inhibition 10 minutes after abciximab bolus MAX and the mean platelet aggregation inhibition 10 minutes after abciximab bolus MEAN
The secondary CLINICAL end-points of the study are
The composite of death stroke repeat myocardial infarction urgent target vessel revascularization and major bleedings at 30 days following primary PCI
The composite of cardiovascular death repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up
The secondary ANGIOGRAPHIC end-points of the study are
The proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel
The restenosis rate diameter stenosis 50 and late loss in the culprit vessel at 6-months follow-up
Other exploratory end-points are the feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI the cardiac MRI measurements and platelet aggregation inhibition at 6h post-PCI
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