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Stroke prophylaxis with Apixaban in CKD5 patients with atrial fibrillation (SACK) (EU CTIS 2022-501600-10-00)

This is a pragmatic prospective open endpoint randomized controlled clinical trial where the primary objective is to evaluate if treatment with apixaban reduces the risk of ischemic stroke in patients with CKD stage 5 and AF without causing an unacceptable increase in the risk of fatal bleeding and intracranial bleeding (including hemorrhagic stroke).  The secondary objectives are to evaluate the risk of major bleedings as compared with no treatment and to evaluate if treatment with apixaban reduces all-cause mortality, and cardiovascular events in patients with CKD stage 5 and AF.

Karolinska University hospital is the sponsor of this trial supported by a grant from the Swedish Research Council. The application has been approved by the Ethics Review Authority and the Medical Products Agency in the participating countries. In total, 1000 - 1400 people from five European countries will patricipate in the study.