Karlshamn

Researchers are evaluating the safety and effectiveness of apixaban to prevent strokes in adults with stage 5 chronic kidney disease (CKD) who also have atrial fibrillation (AF), a heart rhythm disorder. This phase 3b clinical trial compares apixaban treatment to no anticoagulation to see if apixaban lowers the risk of ischemic stroke without causing unacceptable increases in fatal or brain bleeding. The study also looks at the risk of death from any cause, cardiovascular events, and major bleeding in this patient group. Participants are randomly assigned to receive either apixaban 2.5 mg tablets twice daily along with standard care or standard care without anticoagulation. The study is open-label, meaning both patients and doctors know the treatment given. Apixaban will be prescribed and renewed by the local investigator. The study lasts between 12 and 72 months and includes about 1000 to 1400 patients from multiple sites in Sweden, Finland, Norway, Iceland, Poland, and possibly other European countries. During the study, participants will have routine blood tests including kidney function and coagulation checks. Researchers will monitor the time to first ischemic stroke, fatal or intracranial bleeding, overall mortality, cardiovascular events, and major bleeding events. A safety board will oversee the trial, and outcomes will be reviewed independently. The study may also explore outcomes related to kidney transplant complications and thrombosis. Participation ends after 72 months or when enough primary events have occurred.