Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 4:09 AM
Study NCT ID:
NCT05732506
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
Sponsor:
Galaxia Empírica
Organization:
Study Overview
Official Title:
Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
Status:
COMPLETED
Status Verified Date:
2025-04
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:
The aim of the present study is to prospectively evaluate the safety of Edoxaban.
Detailed Description:
The aim of the present study is to prospectively evaluate the safety of Edoxaban in daily clinical practice in Spain in elderly patients with nonvalvular atrial fibrillation who meet the criteria for frailty and who have been prescribed the drug recently (\<6 months prior to inclusion).
The study will provide us with a clear and real-life picture of bleeding and ischemic complications and possible treatment interruptions with Edoxaban in real life and in a large subgroup, although underrepresented in the studies.
The study will provide us with a clear and real-life picture of bleeding and ischemic complications and possible treatment interruptions with Edoxaban in real life and in a large subgroup, although underrepresented in the studies.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: