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

NCT06606275 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

  • End-Stage Kidney Disease (ESKD)
  • Non-valvular Atrial Fibrillation (NVAF)
  • Venous Thromboembolism (VTE)

Interventions

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).

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.

Sponsors & Collaborators

  • United Arab Emirates University

    collaborator OTHER

  • Cleveland Clinic Abu Dhabi

    collaborator OTHER

  • Abu Dhabi Health Services Company

    lead OTHER_GOV

Principal Investigators

  • Mosab Albalas, PharmD · Tawam Hospital

  • Said Nabil, MS, PharmD · Abu Dhabi Health Services Co. SEHA

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-11-04
Completion
2024-11-05

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06606275 on ClinicalTrials.gov