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Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987711
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation End Stage Renal Failure on Dialysis Drug: Warfarin Drug: Apixaban Other: No oral anticoagulation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-D)
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: Coumadin

Active Comparator: 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).
Drug: 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).
Other Name: Eliquis

Active Comparator: No oral anticoagulation
Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
Other: No oral anticoagulation
No oral anticoagulation




Primary Outcome Measures :
  1. Recruitment of the target population within 2 years [ Time Frame: 2 years from start of trial ]
  2. 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. [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%. [ Time Frame: 26 weeks ]
  2. >95% of randomized patients adhere to the enrollment criteria with respect to atrial fibrillation or atrial flutter [ Time Frame: End of trial ]
    Through adjudication of ECGs or other cardiac diagnostics

  3. Major bleeding [ Time Frame: 26 weeks ]
    As defined by the International Society of Thrombosis and Haemostasis (ISTH)

  4. Clinically relevant non-major bleeding [ Time Frame: 26 weeks ]
    As defined by the International Society of Thrombosis and Haemostasis (ISTH)

  5. Stroke and systemic embolism [ Time Frame: 26 weeks ]
  6. All cause mortality [ Time Frame: 26 weeks ]
  7. Non-fatal myocardial infarction [ Time Frame: 26 weeks ]
  8. Vascular events not related to dialysis access [ Time Frame: 26 weeks ]
  9. Events of special interest related to dialysis access, the dialysis procedure or the oral anticoagulants [ Time Frame: 26 weeks ]
    Thrombosis of fistula or graft; fistula or graft abandonment; thrombosis of dialysis catheter; red blood cell transfusions; calciphylaxis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  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:

  1. Moderate or severe mitral stenosis.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987711


Contacts
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Contact: Ziv Harel 416-360-4000 ext 8462 ziv.harel@unityhealth.to
Contact: Ron Wald 416-867-3703 ron.wald@unityhealth.to

Locations
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Canada, Nova Scotia
Nova Scotia Health Authority, QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Karthik Tennankore    902-473-2099    karthikk.tennankore@nshealth.ca   
Principal Investigator: Karthik Tennankore         
Sub-Investigator: David Clark         
Sub-Investigator: Steven Soroka         
Sub-Investigator: Amanda Vinson         
Canada, Ontario
Lakeridge Health Oshawa Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Andrew Steele    905-576-8711 x33200    asteele@lh.ca   
Principal Investigator: Andrew Steele         
Sub-Investigator: Nancy Barrese         
Sub-Investigator: George Buldo         
Sub-Investigator: Charles Wei         
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Rey Acedillo    807-684-7566    acedillr@tbh.net   
Principal Investigator: Rey Acedillo         
Sub-Investigator: Nasim Shahbazi         
Unity Health Toronto, at its St. Michael's Hospital site Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Ziv Harel    416-360-4000 ext 8462    ziv.harel@unityhealth.to   
Principal Investigator: Ziv Harel         
Sub-Investigator: Ron Wald         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 3E4
Contact: William Beaubien-Souligny    514-377-3733    william.beaubien@gmail.com   
Principal Investigator: William Beaubien-Souligny         
Sub-Investigator: Alexandre Granger-Vallée         
Jewish General Hospital Recruiting
Montréal, Quebec, Canada, H3T 1E2
Contact: Daniel Blum    514-340-8222 x24249    daniel.blum@mcgill.ca   
Principal Investigator: Daniel Blum         
Hôpital du Sacré-Cœur de Montréal Recruiting
Montréal, Quebec, Canada, H4J 1C5
Contact: François Madore    514-338-2222    f.madore@umontreal.ca   
Principal Investigator: François Madore         
Sub-Investigator: Rémi Goupil         
Canada, Saskatchewan
Regina General Hospital Recruiting
Regina, Saskatchewan, Canada, S4P 0W5
Contact: Bhanu Prasad    306-352-3018    bprasad@sasktel.net   
Principal Investigator: Bhanu Prasad         
Sub-Investigator: Payam Dehghani         
Canada
CHU de Québec - Université Laval Recruiting
Québec, Canada, G1R 2J6
Contact: Fabrice Mac-Way    418-525-4444 x15464    fabrice.mac-way@chudequebec.ca   
Principal Investigator: Fabrice Mac-Way         
Sub-Investigator: Simon Desmeules         
Sub-Investigator: Mathieu Rousseau-Gagnon         
Sub-Investigator: Sébastien Xavier Joncas         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Ziv Harel St. Michael's Hospital, Toronto
Principal Investigator: Ron Wald St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03987711    
Other Study ID Numbers: SAFE-D-01
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Warfarin
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action