| Trial ID: | L1330 |
| Source ID: | NCT02933697
|
| Associated Drug: |
Apixaban
|
| Title: |
Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD)
|
| Acronym: |
AXADIA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Atrial Fibrillation|End-stage Kidney Disease
|
| Interventions: |
DRUG: Apixaban|DRUG: Phenprocoumon
|
| Outcome Measures: |
Primary: 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., 1-60 months | Secondary: 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, 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, 1-60 months
|
| Sponsor/Collaborators: |
Sponsor: Atrial Fibrillation Network | Collaborators: Bristol-Myers Squibb|Pfizer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
108
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-06-20
|
| Completion Date: |
2022-07-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-09-27
|
| Locations: |
Universitätsklinikum Münster, Münster, 48149, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02933697
|
