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

NCT06606275 | Completed

• 1 other identifier: KD/AJ/1063
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Warfarin; Apaxiban

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  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 Outcomes (1)

• Dose appropriateness

  Up to 6 months

Study Arms (2)

Apixaban arm

Patient who were receiving warfarin while on dialysis

Drug: Apixaban

Warfarin arm

Patient who were receiving warfarin while on dialysis

Drug: Warfarin

Interventions

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).

Apixaban arm

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.

Warfarin arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abu Dhabi Health Services Company: lead
• United Arab Emirates University: collaborator
• Cleveland Clinic Abu Dhabi: collaborator

Study Sites (1)

SEHA Tawam Hospital

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Location

Related Publications (5)

• 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.

  PMID: 34078109 BACKGROUND

• 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.

  PMID: 25040558 BACKGROUND

• 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.

  PMID: 33073581 BACKGROUND

• 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.

  PMID: 32538234 BACKGROUND

• 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.

  PMID: 33709339 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Venous Thromboembolism

Interventions

apixaban; Warfarin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mosab Albalas, PharmD

  Tawam Hospital

  STUDY DIRECTOR

• Said Nabil, MS, PharmD

  Abu Dhabi Health Services Co. SEHA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 20, 2024
• Study Start: January 1, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 5, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)