Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation
Status:
Not yet recruiting
Trial end date:
2028-12-01
Target enrollment:
Participant gender:
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)