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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
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
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
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
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 or atrial flutter
Through adjudication of ECGs or other cardiac diagnostics
Time frame: End of trial
Major bleeding
As defined by the International Society of Thrombosis and Haemostasis (ISTH)
Time frame: 26 weeks
Clinically relevant non-major bleeding
As defined by the International Society of Thrombosis and Haemostasis (ISTH)
Time frame: 26 weeks
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
Thrombosis of fistula or graft; fistula or graft abandonment; thrombosis of dialysis catheter; red blood cell transfusions; calciphylaxis
Time frame: 26 weeks
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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
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