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Using apixaban to prevent strokes in patients with severe kidney disease and atrial fibrillation

Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation

Phase 3 Interventional Region Stockholm · NCT05679024

This study is testing if the blood thinner apixaban can help prevent strokes in people with severe kidney disease and atrial fibrillation.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1400 (estimated)
Ages18 Years and up
SexAll
SponsorRegion Stockholm Government
Locations34 sites (Helsinki and 33 other locations)
Trial IDNCT05679024 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of apixaban as a preventive treatment for strokes in patients with chronic kidney disease stage 5 who also have atrial fibrillation. The study will compare the incidence of ischemic strokes in patients receiving apixaban versus those not receiving anticoagulation therapy. It will also assess the risks of all-cause mortality, cardiovascular events, and major bleeding. The trial will involve 1000-1400 participants across approximately 50 sites in Sweden, Finland, Norway, Iceland, and Poland, and will last between 12 to 72 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic kidney disease stage 5 and a diagnosis of atrial fibrillation.

Not a fit: Patients with atrial fibrillation caused by reversible conditions or those with certain heart valve issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of strokes in patients with severe kidney disease and atrial fibrillation.

How similar studies have performed: While there have been observational studies on anticoagulation in CKD patients, this approach with apixaban specifically in stage 5 CKD is novel and has not been extensively tested in randomized controlled trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed Written Informed Consent
2. 18 years of age or older
3. 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).
4. Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)
5. CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation
6. Women of childbearing potential (WOCBP) should have a negative highly effective pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment

Exclusion Criteria:

Participants may not be included in the study if any of the following criteria are met:

1. AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)
2. Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study
3. Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome).
4. Any contraindication for anticoagulation including

   1. endocarditis
   2. documented intolerance for apixaban
   3. liver disease with documented coagulation disorder
   4. pregnancy or breast feeding
5. Active bleeding or serious bleeding within 3 months, or

   1. documented hemorrhagic blood dyscrasia
   2. patients currently receiving dual antiplatelet therapy
6. Planned for surgery

   1. kidney transplantation with a living donor within 3 months
   2. active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited
   3. valvular heart disease surgery
7. Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the summary of product characteristics (SmPC) of apixaban or regular intake of non-steroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (COX2) inhibitors
8. 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)

Being active on the kidney transplant waiting list is not an exclusion criterion if it is allowed according to the current clinical guidelines at the transplant clinic where the patient is registered. The patient must report changes in waiting list status to the investigator promptly.

Where this trial is running

Helsinki and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney DiseasesAtrial FibrillationStrokeIntracerebral HemorrhageMajor BleedCardiovascular ComplicationDeathKidney Transplant
Last reviewed 2026-06-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.