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NCT02933697: AXADIA

Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD)

Completed Phase 3 Last updated 27 September 2022
What this trial tests

Phase 3 trial testing Apixaban in Atrial Fibrillation in 108 participants. Completed in 31 July 2022.

Timeline
20 June 2017
Primary endpoint
31 July 2022
31 July 2022

Quick facts

Lead sponsorAtrial Fibrillation Network
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment108
Start date20 June 2017
Primary completion31 July 2022
Estimated completion31 July 2022
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Atrial Fibrillation Network

Who can join

18 and older, any sex, with Atrial Fibrillation or End-stage Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Study is an open-labeled, randomized controlled trial, phase IIIb. Its objective is to assess the safety of the factor Xa inhibitor apixaban versus the vitamin-K antagonist (VKA) phenprocoumon in patients with NVAF and ESKD on hemodialysis. The safety will be assessed by means of the incidence of major and clinically relevant, non-major bleeding on anticoagulation.

Publications & conference data

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

  1. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.
    Steffel J, Collins R, Antz M, Cornu P, et al · · 2021 · cited 670× · PMID 33895845 · DOI 10.1093/europace/euab065
  2. Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.
    Byon W, Garonzik S, Boyd RA, Frost CE. · · 2019 · cited 215× · PMID 31089975 · DOI 10.1007/s40262-019-00775-z
  3. Chronic kidney disease and arrhythmias: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.
    Turakhia MP, Blankestijn PJ, Carrero JJ, Clase CM, et al · · 2018 · cited 195× · PMID 29522134 · DOI 10.1093/eurheartj/ehy060
  4. Antithrombotic treatment for secondary prevention of stroke and other thromboembolic events in patients with stroke or transient ischemic attack and non-valvular atrial fibrillation: A European Stroke Organisation guideline.
    Klijn CJ, Paciaroni M, Berge E, Korompoki E, et al · · 2019 · cited 135× · PMID 31984228 · DOI 10.1177/2396987319841187
  5. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial.
    De Vriese AS, Caluwé R, Caluwé R, Van Der Meersch H, et al · · 2021 · cited 125× · PMID 33753537 · DOI 10.1681/asn.2020111566
  6. A Randomized Controlled Trial Comparing Apixaban With the Vitamin K Antagonist Phenprocoumon in Patients on Chronic Hemodialysis: The AXADIA-AFNET 8 Study.
    Reinecke H, Engelbertz C, Bauersachs R, Breithardt G, et al · · 2023 · cited 122× · PMID 36335915 · DOI 10.1161/circulationaha.122.062779
  7. Apixaban versus No Anticoagulation in Patients Undergoing Long-Term Dialysis with Incident Atrial Fibrillation.
    Mavrakanas TA, Mavrakanas TA, Garlo K, Charytan DM. · · 2020 · cited 66× · PMID 32444398 · DOI 10.2215/cjn.11650919
  8. Role of direct oral anticoagulants in patients with kidney disease.
    Derebail VK, Rheault MN, Kerlin BA. · · 2020 · cited 38× · PMID 32107019 · DOI 10.1016/j.kint.2019.11.027

Verify or expand the search:

Other trials of Apixaban

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other Atrial Fibrillation Network trials

Trials by the same sponsor.

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Data sources for this page

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