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RECRUITING
NCT05679024
PHASE3

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

Sponsor: Region Stockholm

View on ClinicalTrials.gov

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

Interventions

DRUG

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