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Clinical Trial Details

Trial ID: L1268
Source ID: NCT05679024
Associated Drug: Apixaban 2.5 Milligram Oral Tablet
Title: Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation
Acronym: SACK
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Atrial Fibrillation|Stroke|Intracerebral Hemorrhage|Major Bleed|Cardiovascular Complication|Death|Kidney Transplant; Complications|Thromboses, Venous
Interventions: DRUG: Apixaban 2.5 milligram Oral Tablet
Outcome Measures: Primary: Ischemic stroke or systemic embolism (efficacy), Time to ischemic stroke or systemic embolism, Up to 72 months|Intracranial bleeding (including hemorrhagic stroke) and fatal bleeding (safety), Time to intracranial or fatal bleeding, Up to 72 months | Secondary: All-cause mortality, Time to death, Up to 72 months|Cardiovascular event, Composite of time to myocardial infarction, cardiovascular intervention or cardiovascular death, Up to 72 months|Individual components of cardiovascular event, Time to myocardial infarction and cardiovascular intervention and cardiovascular death, Up to 72 months|Major bleeding, Time to major bleeding according to ISTH criteria (modified), Up to 72 months|Major bleeding in patients undergoing kidney transplantation, Time to major surgical bleeding according to ISTH criteria, Up to 72 months | Other: Thromboembolic event, Time to transitory ischemic attack, pulmonary embolism, deep vein thrombosis,, Up to 72 months|Dialysis access thrombosis, Time to dialysis access thrombosis, Up to 72 months|Kidney replacement therapy initiation, Time to Kidney replacement therapy initiation, Up to 72 months
Sponsor/Collaborators: Sponsor: Region Stockholm
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1400
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-17
Completion Date: 2028-12-31
Results First Posted:
Last Update Posted: 2024-10-04
Locations: Helsingfors University hospital, Helsinki, Finland|Tampere hospital, Tampere, Finland|Turku hospital, Turku, Finland|Landspitali, the National University hospital of Iceland, Reykjavík, Iceland|Oslo Akershus, Oslo, Norway|Oslo Universitetssjukhus Ullevål, Oslo, Norway|Stavanger hospital, Stavanger, Norway|Tromsö hospital, Tromsø, Norway|Vestfold hospital, Tønsberg, Norway|Falun hospital, Falun, Dalarna, Sweden|Östersund hospital, Östersund, Jämtland, Sweden|Lasarettet i Falun, Falun, Region Dalarna, Sweden|Mora sjukhus, Mora, Region Dalarna, Sweden|Länssjukhuset Kalmar, Kalmar, Region Kalmar Län, Sweden|Kalix hospital, Kalix, Region Norrbotten, Sweden|Skånes University hospital Lund, Lund, Region Skåne, Sweden|Skånes University hospital Malmö, Malmö, Region Skåne, Sweden|Norrland University hospital Umeå, Umeå, Region Västerbotten, Sweden|Sundsvall, Sundsvall, Region Västernorrland, Sweden|Västmanlands sjukhus Västerås, Västerås, Region Västmanland, Sweden|Borås sjukhus, Borås, Region Västra Götaland, Sweden|Sahlgrenska University hospital, Gothenburg, Region Västra Götaland, Sweden|Skaraborg hospital Skövde, Skövde, Region Västra Götaland, Sweden|University hospital Örebro, Örebro, Region Örebro Län, Sweden|Linköping University hospital, Linköping, Region Östergötland, Sweden|Länssjukhuset Ryhov, Jönköping, Sweden|Karlshamns sjukhus, Karlshamn, Sweden|Karlstad Central hospital, Karlstad, Sweden|Norrköpings sjukhus, Norrköping, Sweden|Skellefteå hospital, Skellefteå, Sweden|Karolinska Universitetssjukhuset, Stockholm, 14186, Sweden|Danderyd sjukhus AB, Stockholm, Sweden|Akdemiska sjukhuset Uppsala, Uppsala, Sweden|Varberg hospital, Varberg, Sweden
URL: https://clinicaltrials.gov/show/NCT05679024

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D453 Apixaban small molecule DB06605 Details