A study to demonstrate that a new antikoagulation therapy with apixaban is safe compared to another antikoagulation therapy with phenprocoumon in patients with chronic kidney disease and atrial fibrillation.
- Conditions
- End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment and Atrial FibrillationMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 23.1Level: LLTClassification code 10076412Term: Chronic kidney disease stage 5System Organ Class: 100000004857Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-005503-84-DE
- Lead Sponsor
- Kompetenznetz Vorhofflimmern e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 108
End-stage kidney disease (ESKD) with chronic hemodialysis treatment 3 times per week (with 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79
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 that require chronic anticoagulation (e.g., a prosthetic mechanical heart valve).
Active infective endocarditis
Active COVID-19 infection or symptoms suggeting COVID-19 infection
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
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
Existing Antiphospholipid Syndrome
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method