Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-30 @ 12:55 PM
Study NCT ID:
NCT01325935
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2011-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients
Sponsor:
Associations for Establishment of Evidence in Interventions
Organization:
Study Overview
Official Title:
Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients: A Prospective Multicenter Registry (OPERA)
Status:
COMPLETED
Status Verified Date:
2016-01
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:
OPERA
Brief Summary:
A prospective multicenter registry in real-world Japanese patients undergoing DAPT for three months after stenting. To assess the long-term safety of Endeavor Zotarolimus-eluting stent through noninferiority in the primary endpoint between two different continuous regimen (three and twelve months) groups of DAPT after stenting with Endeavor Zotarolimus-eluting stent in real-world Japanese patients and to examine the optimal duration of DAPT after stenting with Endeavor Zotarolimus-eluting stent. The long-term DAPT group in the present clinical study (to be appropriated from the post-marketing surveillance of Endeavor) should consist of consecutive patients undergoing DAPT for twelve months after stenting, while the short-term DAPT group (to be newly registered in the present clinical study) should consist of patients who are instructed to undergo DAPT for three months after stenting.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: