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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 : June 24, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date June 24, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Recruitment of the target population within 2 years [ Time Frame: 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. [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03987711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%. [ Time Frame: 26 weeks ]
  • >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
  • Major bleeding [ Time Frame: 26 weeks ]
    As defined by the International Society of Thrombosis and Haemostasis (ISTH)
  • Clinically relevant non-major bleeding [ Time Frame: 26 weeks ]
    As defined by the International Society of Thrombosis and Haemostasis (ISTH)
  • Stroke and systemic embolism [ Time Frame: 26 weeks ]
  • All cause mortality [ Time Frame: 26 weeks ]
  • Non-fatal myocardial infarction [ Time Frame: 26 weeks ]
  • Vascular events not related to dialysis access [ Time Frame: 26 weeks ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Time in the Therapeutic Range [ Time Frame: 26 weeks ]
    Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%.
  • >95% of enrolled patients meet enrollment criteria with respect to atrial fibrillation [ Time Frame: End of trial ]
    Through adjudication of ECGs or other cardiac diagnostics
  • Major bleeding [ Time Frame: 26 weeks ]
    As defined by the International Society of Thrombosis and Haemostasis (ISTH)
  • Clinically relevant non-major bleeding [ Time Frame: 26 weeks ]
    As defined by the International Society of Thrombosis and Haemostasis (ISTH)
  • Stroke and systemic embolism [ Time Frame: 26 weeks ]
  • All-cause mortality, [ Time Frame: 26 weeks ]
  • Non-fatal myocardial infarction [ Time Frame: 26 weeks ]
  • Vascular events not related to dialysis access [ Time Frame: 26 weeks ]
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strategies for the Management of Atrial Fibrillation in patiEnts Receiving HemoDialysis
Official Title  ICMJE Strategies for the Management of Atrial Fibrillation in patiEnts Receiving HemoDialysis (SAFE-HD)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • End Stage Renal Failure on Dialysis
Intervention  ICMJE
  • 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
  • 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
  • Other: No oral anticoagulation
    No oral anticoagulation
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Warfarin
  • 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).
    Intervention: Drug: Apixaban
  • Active Comparator: No oral anticoagulation
    Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
    Intervention: Other: No oral anticoagulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987711
Other Study ID Numbers  ICMJE SAFE-HD-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE Not Provided
PRS Account St. Michael's Hospital, Toronto
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP