AXADIA - AFNET 8

Title
A Safety Study Assessing Oral Anticoagulation with Apixaban versus Vitamin-K Antagonists in Patients with Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment (AXADIA)

Study outline

The primary hypothesis of the study is that oral anticoagulation with apixaban will improve the safety by significantly reducing bleeding rates in patients with ESKD on hemodialysis and NVAF compared to the VKA phenprocoumon.

Flyer for Investigators (available in German only)

Current Status
45 patients
enrolled
24 sites open for recruitment
Status as of 28th September 2018, updates are carried out quarterly.

Planned Number of Patients
222

Participating Countries
Germany

Co-ordinating Investigator Cardiology/ Head of the Trial:
Holger Reinecke, MD, University Hospital, Muenster , Germany

Co-ordinating Investigator Nephrology/ Chief Investigator:
Christoph Wanner, MD, University Hospital Wuerzburg, Germany

Overall Responsibility
Legal Sponsor according to the EU directive 2001/ 20/ EC:
Kompetenznetz Vorhofflimmern e.V. (Atrial Fibrillation NETwork - AFNET), Münster, Germany

Publications
Reinecke H, Jürgensmeyer S, Engelbertz C, et al. 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:e022690. doi: 10.1136/bmjopen-2018-022690

Registration
ClinicalTrials.gov: NCT02933697
EudraCT Nummer: 2015- 005503-84