Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426049
Status:
UNKNOWN
Last Update Posted:
2007-01-24
First Post:
2007-01-23
Brief Title:
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
Sponsor:
German Heart Institute
Organization:
German Heart Institute
Study Overview
Official Title:
Monocenter Double Blinded Prospective Randomized Placebo Controlled Study Investigating Prevention of Major Adverse Cardiac Events MACEs Within 6 Months by Systemic Treatment With Everolimus After Coronary Intervention With Bare Metal Stents in Patients With Significant Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2007-01
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:
None
Brief Summary:
The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant coronary artery disease The aim is to reduce Major Adverse Cardiac Events MACEs including death coronary artery bypass grafting CABG to the target vessel Q-wave and non-Q-wave myocardial infarction and target lesion revascularization within the first 6 months after intervention Additionally safety and tolerability of Everolimus at the selected dose in this patient population will be analyzed
Detailed Description:
None
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