Investigating apixaban in stage 5 kidney disease and atrial fibrillation
The SACK study investigates the efficacy and safety of apixaban for stroke prevention in people with stage 5 chronic kidney disease and atrial fibrillation, with or without dialysis. This page provides information about the study design, eligibility criteria and participating centres.
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SACK: apixaban in stage 5 CKD and atrial fibrillation
Study summary
Patients with stage 5 chronic kidney disease and atrial fibrillation face a high risk of both thromboembolic and bleeding complications, while evidence to guide anticoagulation therapy remains limited. This phase IIIb pragmatic randomized controlled trial evaluates the efficacy and safety of apixaban for stroke prevention in patients with stage 5 chronic kidney disease, with or without dialysis treatment, compared with standard anticoagulation therapy.
Which patients may be eligible?
Key inclusion criteria
- Adults (≥18 years) with stage 5 chronic kidney disease, defined as dialysis-dependent or eGFR <15 mL/min/1.73 m².
- Diagnosed with atrial fibrillation or atrial flutter.
- Indication for oral anticoagulation based on an elevated CHA₂DS₂-VASc score.<
Key exclusion criteria
- Atrial fibrillation or atrial flutter secondary to a reversible cause.
- Requirement for chronic anticoagulation for indications other than atrial fibrillation or atrial flutter.
- Contraindications to anticoagulation, including active or recent major bleeding.
- Pregnancy or breastfeeding.
- Significant valvular heart disease, planned kidney transplantation, or any condition deemed by the investigator to preclude study participation.
Eligibility is assessed exclusively by the treating physician or study team.
About this study
Study aim
To evaluate the efficacy and safety of apixaban for stroke prevention in patients with atrial fibrillation and stage 5 chronic kidney disease, with or without dialysis treatment, compared with standard anticoagulation therapy.
Intervention / treatment
Apixaban
Study design
Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase IIIb
Trial duration per participant
12 months
Participating centres
Sint Antonius Ziekenhuis
Relevant links
Contact NEFRO-NL
How can we help you?
Would you like to learn more about NEFRO-NL, our research network or our services? Our project managers are happy to help. Contact us at info@nefro-nl.nl.
Antina de Boer
Project Manager
