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2022-501600-10-00RecruitingPhase 3

SACK

Stroke prophylaxis with Apixaban in Chronic Kidney Disease stage 5 patients with Atrial fibrillation (SACK)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Jun 2026

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Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1281 (estimated)
First submitted
11 Aug 2022
Start date
7 Feb 2023
Lead sponsor
Karolinska University Hospital
EU CT number
2022-501600-10-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1281
  • 61 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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).

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (61)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Helsinki University Central HospitalHelsinkiFinlandRecruiting
Lahti Central HospitalLahtiFinlandRecruiting
Oulu University HospitalOuluFinlandRecruiting
SatasairaalaPoriFinlandRecruiting
Tampere University HospitalTampereFinlandRecruiting
Turku University Central HospitalTurkuFinlandRecruiting
Vaasa Central HospitalVaasaFinlandRecruiting
Expansion Centres Hemodialyse OuestLavalFranceNot yet recruiting
Hospices Civils de LyonPierre-BéniteFranceNot yet recruiting
Aura ParisSt Ouen Sur SeineFranceNot yet recruiting
LandspitaliReykjavikIcelandRecruiting
Sint Antonius Ziekenhuis StichtingNieuwegeinNetherlandsRecruiting
Helse Bergen HFBergenNorwayRecruiting
Drammen SykehusDrammenNorwayRecruiting
Akershus University HospitalLorenskogNorwayRecruiting
Lovisenberg Diakonale Sykehus ASOsloNorwayRecruiting
Oslo University Hospital HFOsloNorwayRecruiting
Stavanger University HospitalStavangerNorwayRecruiting
Vestfold Hospital TrustTonsbergNorwayRecruiting
University Hospital Of North Norway HFTromsoeNorwayRecruiting
St. Olavs hospital HFTrondheimNorwayRecruiting
Uniwersytecki Szpital Kliniczny w BialymstokuBialystokPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracowPolandRecruiting
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W KatowicachKatowicePolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W LodziLodzPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W LodziLodzPolandRecruiting
Wojewódzki Szpital Specjalistyczny w OlsztynieOlsztynPolandRecruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsawPolandRecruiting
Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i AdministracjiWarszawaPolandRecruiting
Soedra Alvsborg Hospital Vastra GoetalandsregionenBorasSwedenRecruiting
Danderyds Sjukhus ABDanderydSwedenRecruiting
Hoglandssjukhuset Eksjo-Region Jonkopings LanEksjoSwedenRecruiting
Malarsjukhuset EskilstunaEskilstunaSwedenRecruiting
Region DalarnaFalunSwedenRecruiting
Region GaevleborgGavleSwedenRecruiting
Sahlgrenska University Hospital - Vastra GoetalandsregionenGothenburgSwedenRecruiting
Region HallandHalmstadSwedenRecruiting
Karolinska University HospitalHuddingeSwedenRecruiting
Region Jonkopings LanJonkopingSwedenRecruiting
Lanssjukhuset Kalmar Region Kalmar LanKalmarSwedenRecruiting
Region BlekingeKarlskronaSwedenRecruiting
Region VaermlandKarlstadSwedenRecruiting
Region Skane Kristianstad Central HospitalKristianstadSwedenRecruiting
Linkoping University Hospital Region OstergotlandLinkopingSwedenRecruiting
Region NorrbottenLuleaSwedenRecruiting
Region Skane Skanes UniversitetssjukhusLundSwedenRecruiting
Region Skane Skanes UniversitetssjukhusMalmoSwedenRecruiting
Vrinnevisjukhuset I Norrkoeping Region OestergoetlandNorrkopingSwedenRecruiting
Region SormlandNykopingSwedenRecruiting
Region Oerebro lanOrebroSwedenRecruiting
Region Jämtland HärjedalenÖstersundSwedenRecruiting
Skaraborg Hospital-Vastra GoetalandsregionenSkovdeSwedenRecruiting
Region VaesternorrlandSundsvallSwedenRecruiting
Nu Hospital Group-Vastra GoetalandsregionenTrollhattanSwedenRecruiting
Region VasterbottenUmeaSwedenRecruiting
Norrlands University HospitalUmeåSwedenRecruiting
Uppsala University HospitalUppsalaSwedenRecruiting
Region HallandVarbergSwedenRecruiting
Västerås Central HospitalVästeråsSwedenRecruiting
Region KronobergVaxjoSwedenRecruiting
Region Skane Lasarettet I YstadYstadSwedenRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.