NCT05679024: SACK

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

Recruiting now Phase 3 Last updated 4 October 2024

What this trial tests

Phase 3 trial testing Apixaban 2.5 milligram Oral Tablet in Chronic Kidney Diseases in 1,400 participants. Currently enrolling.

Timeline

17 February 2023

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	Region Stockholm
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,400
Start date	17 February 2023
Primary completion	31 December 2027
Estimated completion	31 December 2028
Sites	34 locations across Sweden, Finland, Iceland, Norway

Drugs / interventions tested

• Apixaban 2.5 milligram Oral Tablet

Conditions studied

• Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Stroke — all drugs for Stroke →
• Intracerebral Hemorrhage — all drugs for Intracerebral Hemorrhage →

Sponsor

Region Stockholm — full company profile →

Who can join

18 and older, any sex, with Chronic Kidney Diseases or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Atrial fibrillation and stroke prevention: 25 years of research at EP Europace journal.
   Lip GYH, Proietti M, Potpara T, Mansour M, et al · · 2023 · cited 115× · PMID 37622590 · DOI 10.1093/europace/euad226
2. Anticoagulation in Patients with Chronic Kidney Disease.
   Elenjickal EJ, Travlos CK, Marques P, Mavrakanas TA. · · 2024 · cited 22× · PMID 38035566 · DOI 10.1159/000535546
3. Anticoagulation for people receiving long-term haemodialysis.
   Natale P, Palmer SC, Ruospo M, Longmuir H, et al · · 2024 · cited 10× · PMID 38189593 · DOI 10.1002/14651858.cd011858.pub2
4. Ten tips to manage oral anticoagulation in hemodialysis patients with atrial fibrillation.
   Heine GH, Schneppe C, Bauersachs R, Eitel I, et al · · 2024 · cited 7× · PMID 39439440 · DOI 10.1093/ckj/sfae270
5. Stroke prevention in atrial fibrillation: A narrative review of current evidence and emerging strategies.
   Askarinejad A, Lane DA, Sadeghipour P, Haghjoo M, et al · · 2025 · cited 6× · PMID 40481780 · DOI 10.1111/eci.70082
6. Treatment strategies of the thromboembolic risk in kidney failure patients with atrial fibrillation.
   Genovesi S, Camm AJ, Covic A, Burlacu A, et al · · 2024 · cited 5× · PMID 38816212 · DOI 10.1093/ndt/gfae121
7. Safety and efficacy of direct oral anticoagulants in chronic kidney disease: a meta-analysis.
   Tham D, Zhao L, Yu W, Kherani J, et al · · 2024 · cited 4× · PMID 39568775 · DOI 10.1016/j.rpth.2024.102584
8. Atrial Fibrillation in Kidney Failure: Challenges in Risk Assessment and Anticoagulation Management.
   Law MM, Tan SJ, Wong MCG, Toussaint ND. · · 2023 · cited 2× · PMID 37547561 · DOI 10.1016/j.xkme.2023.100690