The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with NVAF/ VTE and ESKD on Dialysis (WARD)

November 4, 2024 updated by: Said Nabil, Abu Dhabi Health Services Company

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Apixaban arm
Patient who were receiving warfarin while on dialysis
Drug: Apixaban
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 arm
Patient who were receiving warfarin while on dialysis
Drug: Warfarin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abu Dhabi Health Services Company

Collaborators

United Arab Emirates University
Cleveland Clinic Abu Dhabi

Investigators

  • Study Director: Mosab Albalas, PharmD, Tawam Hospital
  • Principal Investigator: Said Nabil, MS, PharmD, Abu Dhabi Health Services Co. SEHA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

November 4, 2024

Study Completion (Actual)

November 5, 2024

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD/AJ/1063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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