drugset / Trial / NCT03987711

Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis

NCT03987711 ↗

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2019-12-10
Primary completion
2022-12-31
Completion
2022-12-31

Outcome

Mixed primary results

paper The primary outcomes evaluated the following measures of feasibility: (1) recruitment of the target population within 2 years PMID 39495569 ↗

paper recruitment was completed in 30 months PMID 39495569 ↗

paper (2) adherence of >80% of randomized patients to the allocated treatment strategy at the conclusion of follow-up. PMID 39495569 ↗

paper 123 (83%) of participants completed follow-up in their allocated treatment arm. PMID 39495569 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Apixaban Small molecule 2.5 mg —
Comparator Apixaban Small molecule 5 mg —
Subject Warfarin Small molecule — —