SACK
Key facts
- Where
- Boras, Danderyd, Eksjo, Eskilstuna, Falun, Gavle, Gothenburg, Halmstad, Huddinge, Jonkoping, Kalmar, Karlskrona, Karlstad, Kristianstad, Linkoping, Lulea, Lund, Malmo, Norrkoping, Nykoping, Orebro, Östersund, Skovde, Sundsvall, Trollhattan, Umea, Umeå, Uppsala, Varberg, Västerås, Vaxjo és Ystad, SvédországSee the 32 sites
- Phase
- 3. fázis
Where in Svédország
- Soedra Alvsborg Hospital Vastra GoetalandsregionenBoras, SvédországTaking people
- Danderyds Sjukhus ABDanderyd, SvédországTaking people
- Hoglandssjukhuset Eksjo-Region Jonkopings LanEksjo, SvédországTaking people
- Malarsjukhuset EskilstunaEskilstuna, SvédországTaking people
- Region DalarnaFalun, SvédországTaking people
- Region GaevleborgGavle, SvédországTaking people
- Sahlgrenska University Hospital - Vastra GoetalandsregionenGothenburg, SvédországTaking people
- Region HallandHalmstad, SvédországTaking people
- Karolinska University HospitalHuddinge, SvédországTaking people
- Region Jonkopings LanJonkoping, SvédországTaking people
- Lanssjukhuset Kalmar Region Kalmar LanKalmar, SvédországTaking people
- Region BlekingeKarlskrona, SvédországTaking people
- Region VaermlandKarlstad, SvédországTaking people
- Region Skane Kristianstad Central HospitalKristianstad, SvédországTaking people
- Linkoping University Hospital Region OstergotlandLinkoping, SvédországTaking people
- Region NorrbottenLulea, SvédországTaking people
- Region Skane Skanes UniversitetssjukhusLund, SvédországTaking people
- Region Skane Skanes UniversitetssjukhusMalmo, SvédországTaking people
- Vrinnevisjukhuset I Norrkoeping Region OestergoetlandNorrkoping, SvédországTaking people
- Region SormlandNykoping, SvédországTaking people
- Region Oerebro lanOrebro, SvédországTaking people
- Region Jämtland HärjedalenÖstersund, SvédországTaking people
- Skaraborg Hospital-Vastra GoetalandsregionenSkovde, SvédországTaking people
- Region VaesternorrlandSundsvall, SvédországTaking people
- Nu Hospital Group-Vastra GoetalandsregionenTrollhattan, SvédországTaking people
- Region VasterbottenUmea, SvédországTaking people
- Norrlands University HospitalUmeå, SvédországTaking people
- Uppsala University HospitalUppsala, SvédországTaking people
- Region HallandVarberg, SvédországTaking people
- Västerås Central HospitalVästerås, SvédországTaking people
- Region KronobergVaxjo, SvédországTaking people
- Region Skane Lasarettet I YstadYstad, SvédországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska University Hospital
- Trial code
- EU 2022-501600-10-00
- Record updated
- 2026. június 23.
- Original description
Our main objective is to study the efficacy and safety of apixaban as stroke prophylaxis in patients with CKD stage 5 and AF with or without dialysis treatment. Our study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke and systemic embolism without causing an unacceptable increase in fatal or intracranial bleedings.Read full original descriptionShow less
Stroke prophylaxis with Apixaban in Chronic Kidney Disease stage 5 patients with Atrial fibrillation (SACK)
Our main objective is to study the efficacy and safety of apixaban as stroke prophylaxis in patients with CKD stage 5 and AF with or without dialysis treatment. Our study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke and systemic embolism without causing an unacceptable increase in fatal or intracranial bleedings.
The primary efficacy objective is to evaluate if treatment with apixaban and standard of care compared to standard of care without anticoagulation decreases the risk of ischemic stroke and systemic embolism (composite) in people with CKD stage 5 and AF (with or without dialysis).
Inclusion: Signed Written informed consent (on paper or digital); Men or women ≥18 years; 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 paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL); CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation; Women of childbearing potential (WOCBP) should have a negative highly sensitive pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug.
Exclusion: Active bleeding or serious bleeding within 3 months, or a) documented hemorrhagic blood dyscrasia or a very high bleeding risk according to investigator, b) patients currently receiving dual antiplatelet therapy; Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the SmPC of apixaban (2,5 mg) or regular intake of NSAID or COX2 inhibitors; Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome); Any contraindication for anticoagulation including a) endocarditis, b) documented intolerance for apixaban, c) liver disease with documented coagulation disorder, d) pregnancy or breast feeding; Planned for surgery a) kidney transplantation with a living donor within 3 months, b) active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited, c) valvular heart disease surgery; Any condition or circumstance in which the patient should not participate in the study according to the study investigator (reason documented in the pre-screening protocol); AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis); Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study.