Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD)
NCT02933697
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- 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) documented by standard or Holter ECG on at least 2 separate days before (or apart from) hemodialysis procedures
- Increased risk of stroke or systemic embolism identified by a CHA2DS2-VASc score of 2 or more as an indication for oral anticoagulation
- Patients with ischemic stroke that meet the above criteria, can be included after more than 3 months if not severely handicapped (modified Rankin scale 0 or 1 of 6, i.e. no symptoms or no significant disability and able to carry out all usual activities, despite some symptoms (Farrell, Godwin, Richards, and Warlow (1991))
- Males and females, aged 18 or older
- AF or atrial flutter due to reversible causes (e.g., thyrotoxicosis, pericarditis)
- Patients with a new onset of hemodialysis within the last 3 months
- Clinically significant (moderate or severe) aortic and mitral stenosis
- Conditions other than AF that require chronic anticoagulation (e.g., a prosthetic
mechanical heart valve).
- Active infective endocarditis
- Any planned interventional or surgical AF or atrial flutter ablation procedure
- Any active bleeding
- A serious bleeding event in the previous 6 months before screening
- Inadequately controlled (HbA1c levels >8.5%) or untreated diabetes
- History of malignant neoplasms at high risk of current bleeding (see summary of
product characteristics (SmPC) of study drugs)
- Known indication for treatment with NSAIDs (see SmPC of study drugs) - acetylsalicylic
acid (ASA) up to 100 mg per day is allowed
- Impaired liver function e.g., caused by active infection with HIV, HBV or HCV,
hepatitis or other liver damage (No limits for ALT and AST values are defined in this
study protocol, although mentioned in the SmPC because they are frequently elevated in
dialysis patients. In case of clinically relevant increase of ALT or AST level,
patient's eligibility is to be decided by the responsible investigator)
- Any type of stroke within 3 months prior to baseline
- Other indication for anticoagulation than NVAF
- Valvular heart disease requiring surgery
- A high risk of bleeding (e.g., active peptic ulcer disease, a platelet count of
<100,000 per cubic millimeter or hemoglobin level of <8 g per deciliter)
- Documented hemorrhagic tendencies or blood dyscrasias
- Current alcohol or drug abuse
- Life expectancy of less than 1 year
- Indication for dual platelet inhibition at baseline (ASA ≤ 100 mg/day is allowed,
clopidrogel is excluded at any dose).
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| Descriptive Information | |||||||||
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| Brief Title ICMJE | Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. | ||||||||
| Detailed Description | 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Reinecke H, Jürgensmeyer 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. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 222 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 2022 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT02933697 | ||||||||
| Other Study ID Numbers ICMJE | AXADIA - AFNET 8 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Atrial Fibrillation Network | ||||||||
| Study Sponsor ICMJE | Atrial Fibrillation Network | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Atrial Fibrillation Network | ||||||||
| Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||