Apixaban to Prevent Stroke in Kidney Failure Patients With Atrial Fibrillation
Tests apixaban against no blood thinner in adults with kidney failure and atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation
Key facts
- Where
- Borås, Falun, Gothenburg, Jönköping, Kalix, Kalmar, Karlshamn, Karlstad, Linköping, Lund, Malmö, Mora, Norrköping, Örebro, Östersund, Skellefteå, Skövde, Stockholm, Sundsvall, Umeå, Uppsala, Varberg, and Västerås, SwedenSee the 25 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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 very advanced chronic kidney disease (stage 5) and atrial fibrillation or atrial flutter. They may be on dialysis or not. It tests apixaban against no anticoagulation to prevent stroke.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- 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 value below 15 ml/min/1.73 m2 in the last 12 months. Atrial fibrillation or atrial flutter with CHA2DS2-VASc score 2 or more for men, 3 or more for women.
- Earlier treatment
- Cannot join if currently taking strong inhibitors of both CYP3A4 and P-glycoprotein, or regularly taking NSAIDs or COX2 inhibitors, or currently on dual antiplatelet therapy.
Main reasons for not taking part
- Atrial fibrillation or flutter from 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 anticoagulation, such as a mechanical heart valve
- Contraindication to anticoagulation, such as endocarditis, pregnancy, or breast feeding
- Active or serious bleeding within 3 months, or planned surgery such as a living-donor kidney transplant within 3 months
Read by machine on 9 November 2026.
Where in Sweden
- Borås sjukhusBorås, SwedenContact: Achim Barth, MDTaking people
- Falun HospitalFalun, SwedenContact: Anna Sahlander, MDTaking people
- Lasarettet i FalunFalun, SwedenContact: Anna Sahlander, MDTaking people
- Sahlgrenska University HospitalGothenburg, SwedenContact: Gregor Guron, ProfTaking people
- Lanssjukhuset RyhovJönköping, SwedenContact: Maria Stendahl, PhDTaking people
- Kalix hospitalKalix, SwedenContact: Nils Sundberg, MDTaking people
- Länssjukhuset KalmarKalmar, SwedenContact: Nikolaos Rigas, MDNot yet recruiting
- Karlshamns sjukhusKarlshamn, SwedenContact: Jonas Andersson, MDTaking people
- Karlstad Central HospitalKarlstad, SwedenContact: Johan Isaksson, MDTaking people
- Linkoping University HospitalLinköping, SwedenContact: Fredrik Uhlin, RNTaking people
- Skånes University Hospital LundLund, SwedenContact: Mårten Segelmark, ProfTaking people
- Skånes University hospital MalmöMalmö, SwedenContact: Anders Christenssen, ProfTaking people
- Mora sjukhusMora, SwedenContact: Hans Furuland, MDTaking people
- Norrköpings sjukhusNorrköping, SwedenContact: Fredrik Sundelin, MDTaking people
- University Hospital ÖrebroÖrebro, SwedenContact: Piotr Jacuszewski, MDTaking people
- Östersund HospitalÖstersund, SwedenContact: Jan Flesche, MDNot yet recruiting
- Skellefteå hospitalSkellefteå, SwedenContact: Cecilia Johansson, MD, PhDNot yet recruiting
- Skaraborg hospital SkövdeSkövde, SwedenContact: Anna Wärme, MDTaking people
- Danderyd sjukhus ABStockholm, SwedenContact: Karin Bergen, MDTaking people
- Karolinska UniversitetssjukhusetStockholm, SwedenContact: Marie Evans, PhDTaking people
- Sundsvall ...Sundsvall, SwedenContact: Frida Welander, MDTaking people
- Norrland University hospital UmeåUmeå, SwedenContact: Andreas Jonsson, MDTaking people
- Akdemiska sjukhuset UppsalaUppsala, SwedenContact: Kerstin Martala, RNTaking people
- Varberg HospitalVarberg, SwedenContact: Oscar Bratt, MDTaking people
- Västmanlands Sjukhus VästeråsVästerås, SwedenContact: Josefin Mörtberg, MDNot yet recruiting
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 → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Region Stockholm
- Trial code
- NCT05679024
- Record updated
- 4 October 2024
- Original description
Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events.Read full original descriptionShow less
Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation
Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events.
The secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation.
Trial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months.
Trial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (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 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation.
The exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein.
Interventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation.
Outcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)
Inclusion: Signed Written Informed Consent; 18 years of age or older; 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 chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL); CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation; 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: Active bleeding or serious bleeding within 3 months, or; documented hemorrhagic blood dyscrasia; patients currently receiving dual antiplatelet therapy; 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; 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; endocarditis; documented intolerance for apixaban; liver disease with documented coagulation disorder; pregnancy or breast feeding; Planned for surgery; kidney transplantation with a living donor within 3 months; active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited; 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); 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; Participants may not be included in the study if any of the following criteria are met:; 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.