End-Stage Kidney Disease (ESKD)WARDNCT06606275
The Safety and Effectiveness of Warfarin Vs Apixaban in Patients With NVAF/ VTE and ESKD on Dialysis
An observational study of End-Stage Kidney Disease (ESKD) and Non-valvular Atrial Fibrillation (NVAF), run by Abu Dhabi Health Services Company at 1 site in United Arab Emirates.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End-Stage Kidney Disease (ESKD), Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE)
- What is being tested?
- Apixaban and Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 67 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jan 2024to 5 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-pregnant Adult (≥ 18 years), CKD-on-dialysis patients receiving Apixaban or Warfarin for at least 1 month
Who may be able to join
- Age more than 18
- CKD on dialysis for at least 1 month
- NVAF or VTE
- On Apixaban or Warfarin for at least 1 month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
SEHA Tawam Hospital
Al Ain City, Abu Dhabi Emirate
About this study
Official 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
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.
Read the 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).
- Conditions
- End-Stage Kidney Disease (ESKD), Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE)
- Keywords
- Warfarin, Apaxiban
- Medical subject headings
- Kidney Failure, Chronic, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
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).
WarfarinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban arm | Patient who were receiving warfarin while on dialysis Receives: Drug: Apixaban | |
| Warfarin arm | Patient who were receiving warfarin while on dialysis Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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).
Measured: 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
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jan 2024
- Primary completion4 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End-Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abu Dhabi Health Services Company
- Sponsor type
- Other government
- Collaborators
- United Arab Emirates University, Cleveland Clinic Abu Dhabi
- Responsible party
- Principal investigator, Said Nabil, Abu Dhabi Health Services Company
- Investigators
- Mosab Albalas, PharmD, Study director, Tawam HospitalSaid Nabil, MS, PharmD, Principal investigator, Abu Dhabi Health Services Co. SEHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606275
- Sponsor's protocol ID
- KD/AJ/1063
- Acronym
- WARD
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34078109Christiansen 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.
PubMed 25040558Cheung 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.
PubMed 33073581Chen 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.
PubMed 32538234Chen 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.
PubMed 33709339
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06606275
- Acronym / sponsor ID
- WARD / KD/AJ/1063
- Conditions
- End-Stage Kidney Disease (ESKD), Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE)
- Keywords
- Warfarin, Apaxiban
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Abu Dhabi Health Services CompanyOther government
- Collaborators
- United Arab Emirates University, Cleveland Clinic Abu Dhabi
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban arm | – | Drug: ApixabanPatient who were receiving warfarin while on dialysis |
| Warfarin arm | – | Drug: WarfarinPatient who were receiving warfarin while on dialysis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-pregnant Adult (≥ 18 years), CKD-on-dialysis patients receiving Apixaban or Warfarin for at least 1 month
Key inclusion criteria (4 listed)
- Age more than 18
- CKD on dialysis for at least 1 month
- NVAF or VTE
- On Apixaban or Warfarin for at least 1 month
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanApixaban 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 | Apixaban arm |
| WarfarinWarfarin 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. | Drug | Warfarin arm |
Primary outcome
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
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
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).
1 secondary outcome
Dose appropriateness
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Results publication: PubMed 34078109Kelly 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.
- Results publication: PubMed 25040558Christiansen 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.
- Results publication: PubMed 33073581Cheung 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.
- Results publication: PubMed 32538234Chen 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.
- Results publication: PubMed 33709339Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mosab Albalas, PharmD study director
Tawam Hospital
Said Nabil, MS, PharmD principal investigator
Abu Dhabi Health Services Co. SEHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-Stage Kidney Disease (ESKD) and Non-valvular Atrial Fibrillation (NVAF), run by Abu Dhabi Health Services Company at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606275, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.