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Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular Atrial Fibrillation

Sponsored by University Hospital, Caen

About this trial

Last updated 2 years ago

Study ID

23-164

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2/Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started a year ago

What is this trial about?

Several well conducted randomized controlled trials have established the superiority or non-inferiority of oral anticoagulants (OACs) compared with vitamin K antagonists to treat non valvular atrial fibrillation (AF) for the prevention of thromboembolic events, as well as their safety profile (less major bleeding events with OACs) in the general population. Atrial fibrillation is associated with higher morbidity and mortality in patients with ESKD but there is a lack of randomized data in ESKD on hemodialysis and no data on peritoneal dialysis. Therefore, available evidence comes from retrospective observational studies that are notoriously unreliable to estimate treatment effects. In the population of patients with end stage renal disease (ESRD) on peritoneal dialysis, the investigators hypothesize that apixaban will be safer and as effective than warfarin for the management of non valvular AF, with a robust methodology: a randomized controlled trial. Individually, if the study hypothesis is confirmed during this protocol, the benefit could be direct in the experimental arm with less bleeding than in standard-of-care arm. Moreover, the risk of bleeding with apixaban will be reduced with the use of concordant dosing in peritoneal dialysis condition, known from APIDP1 study. Collectively, the investigators hope for an improvement in scientific knowledge that will allow us to optimize the treatment of atrial fibrillation in subjects on peritoneal dialysis, maybe with the help of pharmacodynamics indicator.

What are the participation requirements?

Yes

Inclusion Criteria

- Males and females, age at least 18 years, in ESRD threated with peritoneal dialysis for ≥ 3 months

- Patients with a history of non valvular AF treated by oral anticoagulation or patients initiating oral anticoagulation for a diagnosis of non valvular AF

- CHA2DS2-VASc score of ≥ 2.

No

Exclusion Criteria

- Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin <8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban) • Moderate or severe mitral stenosis

- Conditions other than non valvular AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism

- Life expectancy < 3 months

- Anticipated kidney transplant within the next 3 months

- childbearing potential