The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with NVAF/ VTE and ESKD on Dialysis
- Conditions
- End-Stage Kidney Disease (ESKD)Non-valvular Atrial Fibrillation (NVAF)Venous Thromboembolism (VTE)
- Interventions
- Registration Number
- NCT06606275
- Lead Sponsor
- Abu Dhabi Health Services Company
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- Age more than 18
- CKD on dialysis for at least 1 month
- NVAF or VTE
- On Apixaban or Warfarin for at least 1 month
- Age less than 18
- Received dialysis for less than 1 month (i.e., were treated with dialysis for acute kidney injury).
- On Apixaban or Warfarin for less than 1 month
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Apixaban arm Apixaban Patient who were receiving warfarin while on dialysis Warfarin arm Warfarin Patient who were receiving warfarin while on dialysis
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] From date of enrollment until the date of first bleeding event or date of death from any cause, whichever came first, assessed up to 6 months Safety will be assessed by Major/Minor bleeding incidents based on International Society on Thrombosis and Haemostasis (ISTH) criteria
Effectiveness: VTE From date of enrollment until the date of first documented VTE event or date of death from any cause, whichever came first, assessed up to 6 months Effectiveness will be measured by VTE events based on documented radiography and/or wells score for PE/DVT
Effectiveness: Stroke From date of enrollment until the date of first documented Stroke event or date of death from any cause, whichever came first, assessed up to 6 months The primary outcome is the occurrence of stroke events in the study population, confirmed through clinical evaluation (e.g., neurological assessment) and imaging (CT or MRI). Data will be collected and reported as the number of patients experiencing stroke events during the study period. The incidence will be further categorized by stroke type (ischemic or hemorrhagic) and the severity of the event, using the National Institutes of Health Stroke Scale (NIHSS) for assessment. Aggregated data will include the total number of stroke events, time to occurrence, and any associated patient outcomes (e.g., mortality, disability).
- Secondary Outcome Measures
Name Time Method Dose appropriateness Up to 6 months This measure will evaluate the dose appropriateness of apixaban and warfarin in patients with end-stage kidney disease (ESKD) on dialysis. For apixaban, dose appropriateness will be assessed based on FDA dosing guidelines for patients with renal impairment, including dosage adjustments for specific clinical factors (e.g., age, weight, and concurrent medications). For warfarin, dose appropriateness will be evaluated using the target International Normalized Ratio (INR) range for stroke prevention or VTE management. The data will be aggregated and reported as the number and percentage of patients receiving guideline-concordant doses. In cases where dosing is not appropriate, discrepancies will be documented and analyzed.
Trial Locations
- Locations (1)
SEHA Tawam Hospital
🇦🇪Al Ain, Abu Dhabi, United Arab Emirates