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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| The George Institute for Global Health (Sydney, Australia) | UNKNOWN |
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The prevention of atrial fibrillation related thromboembolism in the dialysis population is unclear. While the practice of anticoagulation appears favorable in patients with mild-to-moderate chronic kidney disease, no patients with severe chronic kidney disease (estimated glomerular filtration rate <25 ml/min), and specifically those receiving dialysis, have been included in randomized trials.Moreover, the effect of anticoagulation in the dialysis population may fundamentally differ from those studied in clinical trials. Accordingly, characterization of the optimal management strategy to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation receiving dialysis is a priority. The overall goal of this pilot trial is to evaluate the feasibility of conducting a randomized controlled trial comparing anticoagulation strategies in patients with atrial fibrillation receiving dialysis (either hemodialysis or peritoneal dialysis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | Experimental | Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0. |
|
| Apixaban | Active Comparator | Individuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants). |
|
| No oral anticoagulation | Active Comparator | Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment of the target population within 2 years | 2 years from start of trial | |
| At least 80% of randomized participants remain in the trial and on the allocated study treatment at the end of the 26-week study period. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%. | 26 weeks | |
| >95% of randomized patients adhere to the enrollment criteria with respect to atrial fibrillation or atrial flutter | Through adjudication of ECGs or other cardiac diagnostics |
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Inclusion Criteria:
Age ≥ 18 years.
Receiving maintenance hemodialysis or peritoneal dialysis for > 90 days.
History of AF or atrial flutter as defined by:
(i) AF or atrial flutter on a 12 lead ECG at enrollment, and not due to a reversible cause, or (ii) AF or atrial flutter documented on two separate occasions, not due to a reversible cause, at least 1 day apart prior to enrollment. AF or atrial flutter may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording, or more than 30 minutes if using pacemaker or implantable cardioverter defibrillator (ICD) recordings, or (iii) AF or atrial flutter documented on one occasion, not due to a reversible cause, prior to enrollment and being treated with an oral anticoagulant for AF or atrial flutter at enrollment. [AF or atrial flutter may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording, or more than 30 minutes if using pacemaker or implantable cardioverter defibrillator (ICD) recordings, or mentioned in the medical record], or (iv) AF or atrial flutter documented on one occasion on ECG, not due to a reversible cause, prior to enrollment and at least one more episode of AF or atrial flutter mentioned in the medical record, or (v) AF or atrial flutter documented on one occasion in a cardiologist report, not due to a reversible condition, prior to enrollment.
Satisfying CHADS-65 criteria: i) Age ≥65 or ii) Age <65 and one of: hypertension, diabetes mellitus, congestive heart failure, stroke/transient ischemic attack or peripheral embolism.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziv Harel | Unity Health Toronto | Principal Investigator |
| Ron Wald | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepean Hospital | Kingswood | New South Wales | 2747 | Australia | ||
| Prince of Wales Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39495569 | Derived | Harel Z, Smyth B, Badve SV, Blum D, Beaubien-Souligny W, Silver SA, Clark E, Suri R, Mavrakanas TA, Sasal J, Prasad B, Eikelboom J, Tennankore K, Rigatto C, Prce I, Madore F, Mac-Way F, Steele A, Zeng Y, Sholzberg M, Dorian P, Yan AT, Sood MM, Gladstone DJ, Tseng E, Kitchlu A, Walsh M, Sapir D, Oliver MJ, Krishnan M, Kiaii M, Wong N, Kotwal S, Battistella M, Acedillo R, Lok C, Weir M, Wald R. Anticoagulation for Patients with Atrial Fibrillation Receiving Dialysis: A Pilot Randomized Controlled Trial. J Am Soc Nephrol. 2025 May 1;36(5):901-910. doi: 10.1681/ASN.0000000000000495. Epub 2024 Nov 4. |
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|
| Apixaban | Drug | Individuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants). |
|
|
| No oral anticoagulation | Other | No oral anticoagulation |
|
| End of trial |
| Major bleeding | As defined by the International Society of Thrombosis and Haemostasis (ISTH) | 26 weeks |
| Clinically relevant non-major bleeding | As defined by the International Society of Thrombosis and Haemostasis (ISTH) | 26 weeks |
| Stroke and systemic embolism | 26 weeks |
| All cause mortality | 26 weeks |
| Non-fatal myocardial infarction | 26 weeks |
| Vascular events not related to dialysis access | 26 weeks |
| Events of special interest related to dialysis access, the dialysis procedure or the oral anticoagulants | Thrombosis of fistula or graft; fistula or graft abandonment; thrombosis of dialysis catheter; red blood cell transfusions; calciphylaxis | 26 weeks |
| Randwick |
| New South Wales |
| 2031 |
| Australia |
| Royal North Shore Hospital | Saint Leonards | New South Wales | 2065 | Australia |
| St. George Hospital | Sydney | Australia |
| Surrey Memorial Hospital | Surrey | British Columbia | V3V 0C6 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Seven Oaks General Hospital | Winnipeg | Manitoba | R2V 3M3 | Canada |
| Nova Scotia Health Authority, QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| Health Sciences North | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| Kingston Health Sciences Centre - Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Halton Healthcare - Oakville Trafalgar Memorial Hospital | Oakville | Ontario | L6M 0L8 | Canada |
| Lakeridge Health Oshawa | Oshawa | Ontario | L1G 2B9 | Canada |
| The Ottawa Hospital - Riverside Campus | Ottawa | Ontario | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4G 3E8 | Canada |
| Unity Health Toronto, at its St. Michael's Hospital site | Toronto | Ontario | M5B 1W8 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M6K3S2 | Canada |
| St. Joseph's Health Centre Toronto | Toronto | Ontario | M6R 1B5 | Canada |
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 3E4 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Hôpital du Sacré-Cœur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| McGill University Health Centre | Montreal | Quebec | H8S 4K4 | Canada |
| CHU de Québec - Université Laval | Québec | Quebec | G1R 2J6 | Canada |
| Regina General Hospital | Regina | Saskatchewan | S4P 0W5 | Canada |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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