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Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation
Sponsor: Region Stockholm
Summary
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1400
Start Date
2023-02-17
Completion Date
2028-12-31
Last Updated
2024-10-04
Healthy Volunteers
No
Conditions
Interventions
Apixaban 2.5 milligram Oral Tablet
Oral Tablet
Locations (34)
Helsingfors University hospital
Helsinki, Finland
Tampere hospital
Tampere, Finland
Turku hospital
Turku, Finland
Landspitali, the National University hospital of Iceland
Reykjavik, Iceland
Oslo Akershus
Oslo, Norway
Oslo Universitetssjukhus Ullevål
Oslo, Norway
Stavanger hospital
Stavanger, Norway
Tromsö hospital
Tromsø, Norway
Vestfold hospital
Tønsberg, Norway
Falun hospital
Falun, Dalarna County, Sweden
Östersund hospital
Östersund, Jämtland County, Sweden
Lasarettet i Falun
Falun, Region Dalarna, Sweden
Mora sjukhus
Mora, Region Dalarna, Sweden
Länssjukhuset Kalmar
Kalmar, Region Kalmar Län, Sweden
Kalix hospital
Kalix, Region Norrbotten, Sweden
Skånes University hospital Lund
Lund, Region Skåne, Sweden
Skånes University hospital Malmö
Malmo, Region Skåne, Sweden
Norrland University hospital Umeå
Umeå, Region Västerbotten, Sweden
Sundsvall
Sundsvall, Region Västernorrland, Sweden
Västmanlands sjukhus Västerås
Västerås, Region Västmanland, Sweden
Borås sjukhus
Borås, Region Västra Götaland, Sweden
Sahlgrenska University hospital
Gothenburg, Region Västra Götaland, Sweden
Skaraborg hospital Skövde
Skövde, Region Västra Götaland, Sweden
University hospital Örebro
Örebro, Region Örebro Län, Sweden
Linköping University hospital
Linköping, Region Östergötland, Sweden
Länssjukhuset Ryhov
Jönköping, Sweden
Karlshamns sjukhus
Karlshamn, Sweden
Karlstad Central hospital
Karlstad, Sweden
Norrköpings sjukhus
Norrköping, Sweden
Skellefteå hospital
Skellefteå, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Danderyd sjukhus AB
Stockholm, Sweden
Akdemiska sjukhuset Uppsala
Uppsala, Sweden
Varberg hospital
Varberg, Sweden