Clinical trial NCT06606275: The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with NVAF/ VTE and ESKD on Dialysis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-Stage Kidney Disease (ESKD)
Non-valvular Atrial Fibrillation (NVAF)
Venous Thromboembolism (VTE)
Keywords: Warfarin
Apaxiban
Lead sponsor: Abu Dhabi Health Services Company
Sponsor class: OTHER_GOV
Collaborators: name: United Arab Emirates University
name: Cleveland Clinic Abu Dhabi
First posted: 2024-09-20
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-pregnant Adult (≥ 18 years), CKD-on-dialysis patients receiving Apixaban or Warfarin for at least 1 month

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).

Eligibility criteria: Inclusion Criteria:

* Age more than 18
* CKD on dialysis for at least 1 month
* NVAF or VTE
* On Apixaban or Warfarin for at least 1 month

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 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
measure: Effectiveness: VTE
timeFrame: 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
measure: Effectiveness: Stroke
timeFrame: 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
Secondary outcomes:
measure: Dose appropriateness
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Al Ain
country: United Arab Emirates
facility: SEHA Tawam Hospital
state: Abu Dhabi
Study officials:
affiliation: Tawam Hospital
name: Mosab Albalas, PharmD
role: STUDY_DIRECTOR
affiliation: Abu Dhabi Health Services Co. SEHA
name: Said Nabil, MS, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelly DM, Ademi Z, Doehner W, Lip GYH, Mark P, Toyoda K, Wong CX, Sarnak M, Cheung M, Herzog CA, Johansen KL, Reinecke H, Sood MM. Chronic Kidney Disease and Cerebrovascular Disease: Consensus and Guidance From a KDIGO Controversies Conference. Stroke. 2021 Jul;52(7):e328-e346. doi: 10.1161/STROKEAHA.120.029680. Epub 2021 Jun 3.
citation: Christiansen CF, Schmidt M, Lamberg AL, Horvath-Puho E, Baron JA, Jespersen B, Sorensen HT. Kidney disease and risk of venous thromboembolism: a nationwide population-based case-control study. J Thromb Haemost. 2014 Sep;12(9):1449-54. doi: 10.1111/jth.12652. Epub 2014 Jul 29.
citation: Cheung CYS, Parikh J, Farrell A, Lefebvre M, Summa-Sorgini C, Battistella M. Direct Oral Anticoagulant Use in Chronic Kidney Disease and Dialysis Patients With Venous Thromboembolism: A Systematic Review of Thrombosis and Bleeding Outcomes. Ann Pharmacother. 2021 Jun;55(6):711-722. doi: 10.1177/1060028020967635. Epub 2020 Oct 19.
citation: Chen A, Stecker E, A Warden B. Direct Oral Anticoagulant Use: A Practical Guide to Common Clinical Challenges. J Am Heart Assoc. 2020 Jul 7;9(13):e017559. doi: 10.1161/JAHA.120.017559. Epub 2020 Jun 15.
citation: Chen HY, Ou SH, Huang CW, Lee PT, Chou KJ, Lin PC, Su YC. Efficacy and Safety of Direct Oral Anticoagulants vs Warfarin in Patients with Chronic Kidney Disease and Dialysis Patients: A Systematic Review and Meta-Analysis. Clin Drug Investig. 2021 Apr;41(4):341-351. doi: 10.1007/s40261-021-01016-7. Epub 2021 Mar 11.