Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606275
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with NVAF VTE and ESKD on Dialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with Non-Valvular Atrial Fibrillation Venous Thromboembolism and End-Stage Kidney Disease on Dialysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WARD
Brief Summary:
This is a retrospective study of End-Stage Kidney Disease ESKD patients on dialysis receiving apixaban or warfarin at Tawam Hospital a tertiary care hospital in Al Ain UAE The study aims to assess the appropriateness of prescribing apixaban and warfarin in this population and evaluate their safety and effectiveness
Detailed Description:
Direct oral anticoagulants DOACs including apixaban are used for stroke prevention in non-valvular atrial fibrillation NVAF and for venous thromboembolism VTE management Patients with end-stage kidney disease ESKD on dialysis face elevated risks of thromboembolic events and bleeding While apixaban is FDA-approved for use in this population its safety and efficacy compared to warfarin are not well established in this vulnerable population
This retrospective observational study aims to assess the prescribing appropriateness of apixaban compared to warfarin and evaluate their safety and effectiveness in a cohort of ESKD patients undergoing dialysis This study will include ESKD patients on dialysis receiving apixaban or warfarin at Tawam Hospital from May 1 2018 to January 31 2024 Data on demographics anticoagulant dosing therapy duration bleeding events CHA2DS2-VASc score HAS-BLED score and thromboembolic events will be collected Safety will be assessed by bleeding incidents and effectiveness will be measured by VTE and stroke events Dose appropriateness was evaluated according to FDA guidelines for apixaban and INR targets for warfarin Data will be collected for eligible patients through electronic medical records EMR
This retrospective observational study aims to assess the prescribing appropriateness of apixaban compared to warfarin and evaluate their safety and effectiveness in a cohort of ESKD patients undergoing dialysis This study will include ESKD patients on dialysis receiving apixaban or warfarin at Tawam Hospital from May 1 2018 to January 31 2024 Data on demographics anticoagulant dosing therapy duration bleeding events CHA2DS2-VASc score HAS-BLED score and thromboembolic events will be collected Safety will be assessed by bleeding incidents and effectiveness will be measured by VTE and stroke events Dose appropriateness was evaluated according to FDA guidelines for apixaban and INR targets for warfarin Data will be collected for eligible patients through electronic medical records EMR
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