Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187304
Status:
WITHDRAWN
Last Update Posted:
2019-02-04
First Post:
2005-09-15
Brief Title:
ACTION - Anticoagulation Treatment Influence on Post-operative Patients
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial
Status:
WITHDRAWN
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study replaced by an observational study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare two different regimens of therapy AVK and ASA aspirin in the early postoperative period after aortic valve replacement with SJM Epic or SJM Epic Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groupswith special focus on thromboembolic events and bleedings
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