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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Helsingfors University hospital
  Helsinki, Finland Recruiting
• Tampere hospital
  Tampere, Finland Recruiting
• Turku hospital
  Turku, Finland Recruiting
• Landspitali, the National University hospital of Iceland
  Reykjavik, Iceland Recruiting
• Oslo Akershus
  Oslo, Norway Recruiting
• Oslo Universitetssjukhus Ullevål
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Marie Evans, Ass Prof — Karolinska University Hospital
• Study coordinator: Marie Evans, Ass Prof
• Email: marie.evans@regionstockholm.se
• Phone: +46760520852

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.