Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis
NCT ID: NCT03987711
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2019-12-10
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Warfarin
Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
Warfarin
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
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).
Apixaban
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
Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
No oral anticoagulation
No oral anticoagulation
Interventions
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Warfarin
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
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
No oral anticoagulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Receiving maintenance hemodialysis or peritoneal dialysis for \> 90 days.
3. 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.
4. 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
2. Conditions other than non-valvular atrial fibrillation that require oral anticoagulation, such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism.
3. Need for aspirin at a dose \> 165 mg a day, or need for aspirin in combination with P2Y12 antagonist therapy.
4. Need for an interacting drug which precludes the safe use of apixaban.
5. Life expectancy \< 6 months.
6. Scheduled live-donor kidney transplant in the next 6 months.
7. A woman who is pregnant or breastfeeding or unwilling to pursue methods of contraception if \< 12 months since the last menstrual period.
8. Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein.
9. Patient's attending physician(s) (e.g., nephrologist and/or cardiologist and/or neurologist) believes that oral anticoagulation is absolutely mandated.
10. Patient's attending physician(s) (e.g., nephrologist and/or cardiologist and/or neurologist) believes that oral anticoagulation is absolutely contraindicated.
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The George Institute for Global Health (Sydney, Australia)
UNKNOWN
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Ziv Harel
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Ron Wald
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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Nepean Hospital
Kingswood, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
St. George Hospital
Sydney, , Australia
Surrey Memorial Hospital
Surrey, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Seven Oaks General Hospital
Winnipeg, Manitoba, Canada
Nova Scotia Health Authority, QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Kingston Health Sciences Centre - Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Halton Healthcare - Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Unity Health Toronto, at its St. Michael's Hospital site
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre Toronto
Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
Countries
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References
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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.
Other Identifiers
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SAFE-D-01
Identifier Type: -
Identifier Source: org_study_id
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