Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01508663
Status:
UNKNOWN
Last Update Posted:
2012-01-12
First Post:
2012-01-03
Brief Title:
The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients Age 75 Years Old With Coronary Artery Disease a Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2012-01
Last Known Status:
RECRUITING
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:
BRAVE
Brief Summary:
The primary purpose of this study is to determine whether PCI added to OMT could be superior over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in elderly patients with coronary artery disease CAD during the additional 12 months
Detailed Description:
Study Design
Prospective randomized multi-center study of each 1600 subjects enrolled
Eligible subjects will be randomized 11 to a PCI added to OMT n800 vs b OMT alonen800
Subsequently subjects in PCI added to OMT group will be randomly assigned to everolimus eluting stentn400 vs zotarolimus eluting stenn400 All subjects will be followed for 1 year after randomization Additional long-term follow-up 2- or 3-year will be preceded in the next plan after 1-year study period
Subjects with CAD who meet all inclusion and exclusion criteria will be included
Clinical and laboratory follow-up should be performed
Prospective randomized multi-center study of each 1600 subjects enrolled
Eligible subjects will be randomized 11 to a PCI added to OMT n800 vs b OMT alonen800
Subsequently subjects in PCI added to OMT group will be randomly assigned to everolimus eluting stentn400 vs zotarolimus eluting stenn400 All subjects will be followed for 1 year after randomization Additional long-term follow-up 2- or 3-year will be preceded in the next plan after 1-year study period
Subjects with CAD who meet all inclusion and exclusion criteria will be included
Clinical and laboratory follow-up should be performed
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