Tests apixaban to prevent stroke in people with kidney failure and atrial fibrillation
Tests the blood thinner apixaban in adults with kidney failure and irregular heartbeat.
Key facts
- Who runs it
- Karolinska University Hospital
- Where
- Helsinki, Lahti, Oulu, Pori, Tampere, Turku, and Vaasa, FinlandSee the 7 sitesAlso in 6 other countries, 54 sites
- Trial code
- Registry title
- SACK
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,281 people, planned
- Started
- 7 Feb 2023
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional
- Record updated
- 23 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atrial fibrillation or atrial flutter and stage 5 chronic kidney disease, on dialysis or not, to test apixaban for stroke prevention.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Atrial fibrillation or atrial flutter, plus chronic kidney disease stage 5: on chronic dialysis, or eGFR below 20 ml/min/1.73 m2 at least twice 3 months apart, with at least one result below 15 ml/min/1.73 m2 in the last 12 months. CHA2DS2-VASc score of 2 or more for men, 3 or more for women.
Main reasons for not taking part
- Atrial fibrillation or flutter due to a reversible cause, such as thyrotoxicosis or pericarditis
- Rheumatic mitral stenosis, or moderate-to-severe non-rheumatic mitral stenosis
- Another condition that needs long-term blood thinners, such as a mechanical heart valve
- Active or serious bleeding within 3 months, or dual antiplatelet therapy
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Signed Written informed consent (on paper or digital)
- Men or women ≥18 years
- 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)
- Diagnosis of paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)
- CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation
- Women of childbearing potential (WOCBP) should have a negative highly sensitive pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug
Who cannot take part
- Active bleeding or serious bleeding within 3 months, or a) documented hemorrhagic blood dyscrasia or a very high bleeding risk according to investigator, b) patients currently receiving dual antiplatelet therapy
- Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the SmPC of apixaban (2,5 mg) or regular intake of NSAID or COX2 inhibitors
- Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome)
- Any contraindication for anticoagulation including a) endocarditis, b) documented intolerance for apixaban, c) liver disease with documented coagulation disorder, d) pregnancy or breast feeding
- Planned for surgery a) kidney transplantation with a living donor within 3 months, b) active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited, c) valvular heart disease surgery
- 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)
- AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)
- Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study
Where in Finland
Also in 6 other countries, 54 sites
- Helsinki University Central HospitalHelsinki, FinlandTaking people
- Lahti Central HospitalLahti, FinlandTaking people
- Oulu University HospitalOulu, FinlandTaking people
- SatasairaalaPori, FinlandTaking people
- Tampere University HospitalTampere, FinlandTaking people
- Turku University Central HospitalTurku, FinlandTaking people
- Vaasa Central HospitalVaasa, FinlandTaking people
About the trial
What the trial wants to find out
Our main objective is to study the efficacy and safety of apixaban as stroke prophylaxis in patients with CKD stage 5 and AF with or without dialysis treatment. Our study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke and systemic embolism without causing an unacceptable increase in fatal or intracranial bleedings.
Read full original descriptionShow less
The primary efficacy objective is to evaluate if treatment with apixaban and standard of care compared to standard of care without anticoagulation decreases the risk of ischemic stroke and systemic embolism (composite) in people with CKD stage 5 and AF (with or without dialysis).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Stroke prophylaxis with Apixaban in Chronic Kidney Disease stage 5 patients with Atrial fibrillation (SACK)
- Plain-language title
- Tests apixaban to prevent stroke in people with kidney failure and atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 23 June 2026