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

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Helsingfors University hospital
RECRUITING
Helsinki
Tampere hospital
RECRUITING
Tampere
Turku hospital
RECRUITING
Turku
Iceland
Landspitali, the National University hospital of Iceland
RECRUITING
Reykjavík
Norway
Oslo Akershus
RECRUITING
Oslo
Oslo Universitetssjukhus Ullevål
RECRUITING
Oslo
Stavanger hospital
RECRUITING
Stavanger
Vestfold hospital
ACTIVE_NOT_RECRUITING
Tønsberg
Tromsö hospital
RECRUITING
Tromsø
Sweden
Borås sjukhus
RECRUITING
Borås
Falun hospital
RECRUITING
Falun
Lasarettet i Falun
RECRUITING
Falun
Sahlgrenska University hospital
RECRUITING
Gothenburg
Länssjukhuset Ryhov
RECRUITING
Jönköping
Kalix hospital
RECRUITING
Kalix
Länssjukhuset Kalmar
NOT_YET_RECRUITING
Kalmar
Karlshamns sjukhus
RECRUITING
Karlshamn
Karlstad Central hospital
RECRUITING
Karlstad
Linköping University hospital
RECRUITING
Linköping
Skånes University hospital Lund
RECRUITING
Lund
Skånes University hospital Malmö
RECRUITING
Malmö
Mora sjukhus
RECRUITING
Mora
Norrköpings sjukhus
RECRUITING
Norrköping
University hospital Örebro
RECRUITING
Örebro
Östersund hospital
NOT_YET_RECRUITING
Östersund
Skellefteå hospital
NOT_YET_RECRUITING
Skellefteå
Skaraborg hospital Skövde
RECRUITING
Skövde
Danderyd sjukhus AB
RECRUITING
Stockholm
Karolinska Universitetssjukhuset
RECRUITING
Stockholm
Sundsvall
RECRUITING
Sundsvall
Norrland University hospital Umeå
RECRUITING
Umeå
Akdemiska sjukhuset Uppsala
RECRUITING
Uppsala
Varberg hospital
RECRUITING
Varberg
Västmanlands sjukhus Västerås
NOT_YET_RECRUITING
Västerås
Contact Information
Primary
Marie Evans, Ass Prof
marie.evans@regionstockholm.se
+46760520852
Backup
Caroline Moberg
caroline.moberg@ucr.uu.se
Time Frame
Start Date: 2023-02-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1400
Treatments
Active_comparator: Apixaban 2.5 mg twice daily and standard of care
Apixaban 2.5 mg twice daily (low dose) and all other standard of care
No_intervention: Standard of care and no anticoagulation
All other Standard of care and no anticoagulation
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov