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Completed

NCT Number: NCT06606275

The Safety and Effectiveness of Warfarin Vs Apixaban in Patients With NVAF/ VTE and ESKD on Dialysis

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.

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Key information

Conditions

End-Stage Kidney Disease (ESKD) Cardiovascular Diseases Chronic Disease Disease Attributes Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Non-valvular Atrial Fibrillation (NVAF) Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Thromboembolism Urogenital Diseases Urologic Diseases Vascular Diseases Venous Thromboembolism Venous Thromboembolism (VTE)

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SEHA Tawam Hospital

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

Apixaban is a direct oral anticoagulant (DOAC) that inhibits factor Xa, playing a crucial role in preventing blood clot formation. It is commonly prescribed for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) and for treating and preventing venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).

Warfarin

Drug

Warfarin is a vitamin K antagonist widely used as an anticoagulant to prevent thromboembolic events, particularly in conditions like atrial fibrillation, venous thromboembolism, and in patients with mechanical heart valves. It inhibits the enzyme vitamin K epoxide reductase, thereby reducing the activation of vitamin K-dependent clotting factors (II, VII, IX, X) and regulatory proteins C and S. Due to its narrow therapeutic index, warfarin requires regular monitoring of the International Normalized Ratio (INR) to optimize anticoagulation while minimizing the risk of bleeding. Warfarin's pharmacokinetics and pharmacodynamics can be influenced by genetic polymorphisms, diet, and drug interactions, necessitating individualized dosing strategies.

Primary outcomes

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

    Time frame: 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

  2. Effectiveness: VTE

    Time frame: 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

  3. Effectiveness: Stroke

    Time frame: 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 outcomes

  1. Dose appropriateness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abu Dhabi Health Services Company

Other Gov

Collaborators

  • Cleveland Clinic Abu Dhabi
  • United Arab Emirates University

Registry information

Official study 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

Acronym: WARD

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 20, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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