AXADIA – AFNET 8 is an investigator‐driven, prospective, parallel‐group, national, multicenter, phase IIIb trial.

The primary outcome is to assess the safety of the factor Xa inhibitor apixaban versus a vitamin-K antagonist 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 as well as specific bleedings in dialysis patients (e.g., after shunt removal) on anticoagulation.

The secondary outcome is to compare the efficacy of the factor Xa inhibitor apixaban with the VKA phenprocoumon regarding prevention of thromboembolic events in patients with ESKD on hemodialysis and AF.

Furthermore a pharmacokinetic sub-study will be performed with a small number of patients (n=28) in the apixaban treatment group in order to investigate/ determine plasma levels of apixaban prior and after hemodialysis.

The trial will be performed/ conducted in about 40 sites in Germany with 222 patients.

Patients are eligible for AXADIA, if they meet following inclusion criteria:

• End-stage kidney disease (ESKD) with chronic hemodialysis treatment 3 times per week (with about 4 hours per dialysis)

• Chronic (i.e. repeated) paroxysmal, persistent or permanent non-valvular atrial fibrillation (NVAF)

• Increased risk of stroke or systemic embolism identified by a CHA2DS2-VASc score  2 an indication for oral anticoagulation

The study participants will be randomized to either receiving apixaban or phenprocoumon (1:1).