Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-02 @ 8:51 PM
Study NCT ID:
NCT02303795
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial
Sponsor:
Hospital do Coracao
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Open Label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban Compared With Vitamin K Antagonism in Patients With Atrial Fibrillation With Bioprosthetic Mitral Valves - RIVER
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).
Detailed Description:
A Phase 2, Randomized, Open label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban compared with vitamin K antagonism in Patients with Atrial Fibrillation with Bioprosthetic Mitral valves - RIVER. Main analysis for the primary endpoint are based on the Restricted Mean Survival Time (RMST) method.
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?: