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临床试验/NCT06606275
NCT06606275已完成不适用

The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with Non-Valvular Atrial Fibrillation/ Venous Thromboembolism and End-Stage Kidney Disease on Dialysis

Abu Dhabi Health Services Company1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
1
主要终点
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Apixaban arm

Patient who were receiving warfarin while on dialysis

干预措施: Apixaban (Drug)

Warfarin arm

Patient who were receiving warfarin while on dialysis

干预措施: Warfarin (Drug)

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

  • Dose appropriateness(Up to 6 months)

研究者

发起方
Abu Dhabi Health Services Company
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Said Nabil

Clinical Pharmacist

Abu Dhabi Health Services Company

研究点 (1)

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