Trials / Completed
CompletedNCT03987711
Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis
Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-D)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Unity Health Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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 | No oral anticoagulation | No oral anticoagulation |
Timeline
- Start date
- 2019-12-10
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2019-06-17
- Last updated
- 2023-06-22
Locations
28 sites across 2 countries: Australia, Canada
Source: ClinicalTrials.gov record NCT03987711. Inclusion in this directory is not an endorsement.