MedTrace Logo

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)

NCT06045858 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2024-08-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Anticoagulation Agents

anticoagulation in peritoneal dialysis patients with non valvular atrial fibrillation during one year

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2027-10-30
Completion
2027-10-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06045858 on ClinicalTrials.gov