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
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
Sites (61)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | Finland | Recruiting |
| Lahti Central Hospital | Lahti | Finland | Recruiting |
| Oulu University Hospital | Oulu | Finland | Recruiting |
| Satasairaala | Pori | Finland | Recruiting |
| Tampere University Hospital | Tampere | Finland | Recruiting |
| Turku University Central Hospital | Turku | Finland | Recruiting |
| Vaasa Central Hospital | Vaasa | Finland | Recruiting |
| Expansion Centres Hemodialyse Ouest | Laval | France | Not yet recruiting |
| Hospices Civils de Lyon | Pierre-Bénite | France | Not yet recruiting |
| Aura Paris | St Ouen Sur Seine | France | Not yet recruiting |
| Landspitali | Reykjavik | Iceland | Recruiting |
| Sint Antonius Ziekenhuis Stichting | Nieuwegein | Netherlands | Recruiting |
| Helse Bergen HF | Bergen | Norway | Recruiting |
| Drammen Sykehus | Drammen | Norway | Recruiting |
| Akershus University Hospital | Lorenskog | Norway | Recruiting |
| Lovisenberg Diakonale Sykehus AS | Oslo | Norway | Recruiting |
| Oslo University Hospital HF | Oslo | Norway | Recruiting |
| Stavanger University Hospital | Stavanger | Norway | Recruiting |
| Vestfold Hospital Trust | Tonsberg | Norway | Recruiting |
| University Hospital Of North Norway HF | Tromsoe | Norway | Recruiting |
| St. Olavs hospital HF | Trondheim | Norway | Recruiting |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Recruiting |
| Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach | Katowice | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi | Lodz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi | Lodz | Poland | Recruiting |
| Wojewódzki Szpital Specjalistyczny w Olsztynie | Olsztyn | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warsaw | Poland | Recruiting |
| Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji | Warszawa | Poland | Recruiting |
| Soedra Alvsborg Hospital Vastra Goetalandsregionen | Boras | Sweden | Recruiting |
| Danderyds Sjukhus AB | Danderyd | Sweden | Recruiting |
| Hoglandssjukhuset Eksjo-Region Jonkopings Lan | Eksjo | Sweden | Recruiting |
| Malarsjukhuset Eskilstuna | Eskilstuna | Sweden | Recruiting |
| Region Dalarna | Falun | Sweden | Recruiting |
| Region Gaevleborg | Gavle | Sweden | Recruiting |
| Sahlgrenska University Hospital - Vastra Goetalandsregionen | Gothenburg | Sweden | Recruiting |
| Region Halland | Halmstad | Sweden | Recruiting |
| Karolinska University Hospital | Huddinge | Sweden | Recruiting |
| Region Jonkopings Lan | Jonkoping | Sweden | Recruiting |
| Lanssjukhuset Kalmar Region Kalmar Lan | Kalmar | Sweden | Recruiting |
| Region Blekinge | Karlskrona | Sweden | Recruiting |
| Region Vaermland | Karlstad | Sweden | Recruiting |
| Region Skane Kristianstad Central Hospital | Kristianstad | Sweden | Recruiting |
| Linkoping University Hospital Region Ostergotland | Linkoping | Sweden | Recruiting |
| Region Norrbotten | Lulea | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus | Lund | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus | Malmo | Sweden | Recruiting |
| Vrinnevisjukhuset I Norrkoeping Region Oestergoetland | Norrkoping | Sweden | Recruiting |
| Region Sormland | Nykoping | Sweden | Recruiting |
| Region Oerebro lan | Orebro | Sweden | Recruiting |
| Region Jämtland Härjedalen | Östersund | Sweden | Recruiting |
| Skaraborg Hospital-Vastra Goetalandsregionen | Skovde | Sweden | Recruiting |
| Region Vaesternorrland | Sundsvall | Sweden | Recruiting |
| Nu Hospital Group-Vastra Goetalandsregionen | Trollhattan | Sweden | Recruiting |
| Region Vasterbotten | Umea | Sweden | Recruiting |
| Norrlands University Hospital | Umeå | Sweden | Recruiting |
| Uppsala University Hospital | Uppsala | Sweden | Recruiting |
| Region Halland | Varberg | Sweden | Recruiting |
| Västerås Central Hospital | Västerås | Sweden | Recruiting |
| Region Kronoberg | Vaxjo | Sweden | Recruiting |
| Region Skane Lasarettet I Ystad | Ystad | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.