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Vortosiran in Atrial Fibrillation
Sponsor: Ribocure Pharmaceuticals AB
Summary
This is a randomised, actively controlled Phase IIb trial to evaluate the safety and pharmacodynamics (PD) of two blinded doses of subcutaneously administered vortosiran and open-label apixaban in patients with AF. The trial consists of three groups including 50 participants each. The participants will be randomized to either the low dose group or the high dose group receiving vortosiran or to the group receiving apixaban. The treatment will be open-label for vortosiran vs apixaban. The vortosiran dose will be blinded to patients and investigators. Both the low- and the high-dose group will receive two doses of vortosiran, the first dose at Day X and the second at Day Y. After 24 weeks, at the end of the vortosiran treatment period, the participants will start an open-label part of the trial and will be switched to standard-of-care apixaban treatment until Week 64 (End of Trial; EOT). Participants in the open-label apixaban arm will receive apixaban as standard of care during the entire trial.
Official title: A Randomised Active-controlled Trial to Assess the Safety and Pharmacodynamics of Two Blinded Doses of Vortosiran and Open-label Apixaban in Patients With Non-valvular Atrial Fibrillation (AF)
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-10-01
Completion Date
2028-08-31
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Vortosiran
Vortosiran, active drug
Vortosiran
Vortosiran, active drug
Apixaban
Comparator, active drug
Locations (15)
Frederiksberg Hospital
Frederiksberg, Denmark
Herlev-Gentofte
Herlev, Denmark
Sykehuset Østfold Kalnes Kardiologisk
Grålum, Norway
Akershus Universitetssykehus Ahus Kardiologisk
Lørenskog, Norway
EMC Silesia spółka z ograniczoną odpowiedzialnością
Katowice, Poland
Centrum Medyczne Vitamedicum
Krakow, Poland
Balsam Medica Sp z o.o.
Raszyn, Poland
Aidport Clinical Trial Hospital
Skorzewo, Poland
Centrum Medyczne LUX MED
Warsaw, Poland
Centrum Badań Klinicznych
Wroclaw, Poland
Centrum Medyczne Oporów
Wroclaw, Poland
Pracownia Badan Klinicznych Salus
Wroclaw, Poland
Danderyds Sjukhus - Hjärtmottagningen
Danderyd, Sweden
SUS Lund, Department of Cardiology
Lund, Sweden
Södersjukhuset, Department of Cardiology
Stockholm, Sweden