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Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation

RecruitingPhase 3Ages 18 Years - anyAllRegion Stockholm
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In plain words

What the trial is, and whether it could suit you

Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events. The secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation. Trial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months. Trial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treat

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Signed Written Informed Consent 2. 18 years of age or older 3. Ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\* \<20 ml/min/1.73 m2 at least twice 3 months apart of which at least one occasion is \<15 ml/min/1.73 m2 due to CKD during the last year (12 months). 4. Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL) 5. CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation 6. Women of childbearing potential (WOCBP) should have a negative highly effective pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment Exclusion Criteria: Participants may not be included in the study if any of the following criteria are met: 1. AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis) 2. Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study 3. Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome). 4. Any contraindication for anticoagulation including 1. endocarditis 2. documented intolerance for apixaban 3. liver disease with documented coagulation disorder 4. pregnancy or breast feeding 5. Active bleeding or serious bleeding within 3 months, or 1. documented hemorrhagic blood dyscrasia 2. patients currently receiving dual antiplatelet therapy 6. Planned for surgery 1. kidney transplantation with a living donor within 3 months 2. active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited 3. valvular heart disease surgery 7. Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the summary of product characteristics (SmPC) of apixaban or regular intake of non-steroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (COX2) inhibitors 8. Any condition or circumstance in which the patient should not participate in the study according to the study investigator (reason documented in the pre-screening protocol) Being active on the kidney transplant waiting list is not an exclusion criterion if it is allowed according to the current clinical guidelines at the transplant clinic where the patient is registered. The patient must report changes in waiting list status to the investigator promptly.
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What it tests

  • Apixaban 2.5 milligram Oral Tablet
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Where

34 sites
Helsingfors University hospital
Helsinki, Finland
Tampere hospital
Tampere, Finland
Turku hospital
Turku, Finland
Landspitali, the National University hospital of Iceland
Reykjavik, Iceland
Oslo Akershus
Oslo, Norway
Oslo Universitetssjukhus Ullevål
Oslo, Norway
Stavanger hospital
Stavanger, Norway
Tromsö hospital
Tromsø, Norway

…and 26 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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