Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) (AXADIA)
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|ClinicalTrials.gov Identifier: NCT02933697|
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation End-stage Kidney Disease||Drug: Apixaban Drug: Phenprocoumon||Phase 3|
AXADIA is an investigator-driven, prospective, parallel-group, single country, multi-center phase IIIb trial to assess the safety of apixaban versus the vitamin-K antagonist phenprocoumon in patients with NVAF and ESKD on hemodialysis treatment. The trial will be conducted in about 25-30 sites in Germany.
The primary goal of this study is to assess the safety of two types of oral anticoagulants in patients with ESKD on hemodialysis with non-valvular atrial fibrillation (NVAF). The novel FXa inhibitor apixaban (at a reduced dose of 2x 2.5 mg/day) will be compared to the vitamin-K antagonist (VKA) phenprocoumon (target range: International Normalized Ratio (INR) 2.0-3.0) regarding bleeding rates during chronic administration for prevention of stroke or systemic embolism.
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.
A pharmacokinetic sub-study will be performed with 28 patients included in the apixaban treatment group to evaluate the systemic exposure of apixaban before and after hemodialysis session in this special population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||July 2022|
Active Comparator: Apixaban
2.5 mg apixaban twice daily for 6 to 24 months
Patients will be instructed to take one tablet of 2.5 mg twice daily: one tablet in the morning and one in the evening at approximately the same time every day (with about 12 hours gap) irrespective of the time of dialysis.
Other Name: Elquis
Active Comparator: Vitamin-K antagonists (Phenprocoumon)
Phenprocoumon by INR (Target: 2.0-3.0) treatment for 6 to 24 months
Subjects in phenprocoumon treatment group will receive phenprocoumon individually adjusted to an INR of 2.0-3.0 as recommended in the appropriate SmPC for AF patients.
Other Name: Marcumar
- Assess the safety of the factor Xa inhibitor apixaban versus a vitamin-K antagonist phenprocoumon in patients with NVAF and ESKD on hemodialysis. [ Time Frame: 6-24 months ]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.
- 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 [ Time Frame: 6-24 months ]
- Pharmacokinetic sub-study to determine plasma serum level [ Time Frame: 6-24 months ]A pharmacokinetic sub-study will be conducted with a small number of patients in the apixaban treatment group (n= 28) in order to determine plasma serum level of apixaban prior and after hemodialysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933697
|Contact: Sabine Jürgensmeyer, Dr.||0049 (0) 251 980 ext email@example.com|
|Contact: Emilia Czarnecki||0049 (0) 251 980 ext firstname.lastname@example.org|
|Münster, Germany, 48149|
|Principal Investigator:||Holger Reinecke, Prof. Dr.||Universitätsklinikum Münster|