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Trial record 56 of 291 for:    warfarin AND anticoagulation

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

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ClinicalTrials.gov Identifier: NCT03987711
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : September 18, 2019
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 hemodialysis.

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 HemoDialysis (SAFE-HD)
Estimated Study Start Date : October 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 [ 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 for > 90 days.
  3. History of atrial fibrillation as defined by (i) Atrial fibrillation on a 12 lead ECG at enrollment, and not due to a reversible cause, or (ii) Atrial fibrillation documented on two separate occasions, not due to a reversible cause, at least 1 day apart in the 12 months prior to enrollment. Atrial fibrillation may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording.
  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 harelz@smh.ca
Contact: Ron Wald 416-867-3703 waldr@smh.ca

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     History of Changes
Other Study ID Numbers: SAFE-HD-01
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019

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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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Warfarin
Kidney Failure, Chronic
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action