drugset / Trial / NCT02933697
Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD)
Phase 3
Completed
108 enrolled
Atrial Fibrillation Network
Bristol-Myers Squibb · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2017-06-20
- Primary completion
- 2022-07-31
- Completion
- 2022-07-31
Publications
- Reinecke H, Engelbertz C, Bauersachs R, Breithardt G, Echterhoff HH, Gerss J, Haeusler KG, Hewing B, Hoyer J, Juergensmeyer S, Klingenheben T, Knapp G, Christian Rump L, Schmidt-Guertler H, Wanner C, Kirchhof P, Goerlich D. A Randomized Controlled Trial Comparing Apixaban With the Vitamin K Antagonist Phenprocoumon in Patients on Chronic Hemodialysis: The AXADIA-AFNET 8 Study. Circulation. 2023 Jan 24;147(4):296-309. doi: 10.1161/CIRCULATIONAHA.122.062779. Epub 2022 Nov 6.
- Reinecke H, Jurgensmeyer S, Engelbertz C, Gerss J, Kirchhof P, Breithardt G, Bauersachs R, Wanner C. Design and rationale of a randomised controlled trial comparing apixaban to phenprocoumon in patients with atrial fibrillation on chronic haemodialysis: the AXADIA-AFNET 8 study. BMJ Open. 2018 Sep 10;8(9):e022690. doi: 10.1136/bmjopen-2018-022690.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Apixaban | Small molecule | 2.5 mg | Oral |
| Comparator | Phenprocoumon | Small molecule | — | Oral |