About

Atrial fibrillation (AF) is a frequent cardiovascular complication in people with chronic kidney disease (CKD), which more than double the risk of stroke. Currently there is a knowledge gap in the efficacy and safety of all anticoagulant treatments in people with CKD stage 5 (glomerular filtration rate <15 ml/min/1.73m² and dialysis). Warfarin has unknown efficacy and increase the risk of bleeding and calcifylaxis. The trials of direct oral anticoagulants (DOAC) excluded patients with creatinine clearance<25 ml/min/1.73m².

Stroke prophylaxis with Apixaban in CKD 5 patients with atrial fibrillation (SACK), is a European pragmatic, prospective, open label, randomized controlled trial where we randomize patients with CKD stage 5 and AF to treatment with apixaban (DOAC) 2.5 mg x 2 and standard of care or standard of care and no oral anticoagulation. Our primary objective is to evaluate if treatment with apixaban reduces the risk of ischemic stroke without causing an unacceptable increase in the risk of intracranial bleeding and fatal bleeding. Our secondary objective is to evaluate the risk of all major bleedings, cardiovascular events, and all-cause mortality. The patients will be followed up to 72 months and the results are estimated by 2028. The results from SACK will contribute important evidence in a population systematically excluded from clinical trials of stroke prophylaxis in AF.