Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD)

  • STATUS
    Recruiting
  • End date
    Jul 6, 2023
  • participants needed
    108
  • sponsor
    Atrial Fibrillation Network
Updated on 6 May 2021
electrocardiogram
stroke
holter monitor
fibrillation
nephropathy
dialysis
phenprocoumon
vitamins
vascular disease
apixaban
atrial flutter
permanent atrial fibrillation
embolism
anticoagulation therapy
chronic haemodialysis

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.

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.

Details
Condition Arrhythmia, Chronic renal failure, Atrial Fibrillation, Stage 5 Chronic Kidney Disease, Atrial Fibrillation (Pediatric), Chronic Kidney Disease Stage 5, CKD Stage 5, Dysrhythmia, end stage renal disease, chronic renal disease, end-stage renal disease, esrd, end-stage renal failure, end stage kidney disease, end stage renal failure
Treatment Phenprocoumon, Apixaban
Clinical Study IdentifierNCT02933697
SponsorAtrial Fibrillation Network
Last Modified on6 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

End-stage kidney disease (ESKD) with chronic hemodialysis treatment 3 times per week (with about at least 3.5 hours per dialysis)
Chronic (i.e. repeated) paroxysmal, persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL) 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

Exclusion Criteria

AF or AFL 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 or AFL that require chronic anticoagulation (e.g., a prosthetic mechanical heart valve)
Active infective endocarditis
Any planned interventional or surgical AF or AFL 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
Known Antiphospholipid Syndrome requiring anticoagulation
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 AF or AFL
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)
Active infection or symptoms suggestive of COVID-19 infection
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