NCT06045858: APIDP2

Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular Atrial Fibrillation: a Prospective, Randomised, Open-label, Blinded End-point Trial (APIDP2)

Not yet recruiting Phase 3 Last updated 9 August 2024

What this trial tests

Phase 3 trial testing Anticoagulation Agents in Atrial Fibrillation in 178 participants. Not yet recruiting.

Timeline

30 October 2024

Primary endpoint
30 October 2027

30 October 2027

Quick facts

Lead sponsor	University Hospital, Caen
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	178
Start date	30 October 2024
Primary completion	30 October 2027
Estimated completion	30 October 2027

Drugs / interventions tested

• Anticoagulation Agents — full drug profile →

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Peritoneal Dialysis Complication — all drugs for Peritoneal Dialysis Complication →

Sponsor

University Hospital, Caen

Who can join

18 and older, any sex, with Atrial Fibrillation or Peritoneal Dialysis Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction:

Several randomised controlled trials have demonstrated that novel oral anticoagulants (NOACs) are safer compared to vitamin K antagonists for the management of non valvular atrial fibrillation (NVAF) to prevent thromboembolic events, in the general population. There is a growing interest in the use of apixaban in patients with End-Stage Renal-Disease (ESRD) undergoing peritoneal dialysis but there is a lack of randomised data in this population.

Design: APIDP2 is a prospective parallel randomised, open-label, blinded endpoint trial.

Participants: Patients with ESRD undergoing chronic Peritoneal Dialysis who have NVAF.

Setting: A total of 178 participants will be recruited from 20 French peritoneal dialysis centers.

Intervention: Eligible patients will be randomly assigned to receive either apixaban at a reduced dose 2.5mg twice daily (dose determined with the previous pharmacokinetic study APIDP1 of apixaban in PD patients) or dose-adjusted to INR target \[2-3\] coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of one year.

The primary outcome is a major or clinically relevant non-major bleeding from randomisation up to Month 12, assessed according to ISTH score. Secondary outcomes encompass an efficacy composite criterion combining stroke or TIA, cardiovascular death, and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to GUSTO and TIMI criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of \[2-3\] in the warfarin arm over one year, and AntiXa apixaban activity in case of bleeding events and at 1, 6, and 12 months of follow-up in the apixaban arm.

Primary outcome analysis: To demonstrate that apixaban is safer than warfarin at one year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found in the ARISTOTLE study among patients with CrCl \[25-30\]ml/min), i.e. 89 patients per group.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non-valvular atrial fibrillation: protocol for a prospective, randomised, open-label, blinded endpoint trial (APIDP2).
   Ficheux M, Peyro-Saint-Paul L, Balayn D, Lecrux B, et al · · 2024 · cited 2× · PMID 39306346 · DOI 10.1136/bmjopen-2024-089353
2. Comparing the efficacy and safety of direct oral anticoagulants with vitamin K antagonists in dialysis patients with nonvalvular atrial fibrillation: a systematic review and meta-analysis.
   Li T, Li T, Xu Y, Gjermeni D, et al · · 2026 · PMID 40719909 · DOI 10.1007/s00392-025-02711-7