Phase 2Not yet recruiting
Vortosiran in Atrial Fibrillation
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)
- Sponsor
- Ribocure Pharmaceuticals AB (Industry)
- Enrolment
- 150 planned
- Conditions
- Non-valvular Atrial Fibrillation (AF)
- Interventions
- Vortosiran; Vortosiran; Apixaban
- Ages
- adults, older adults
- Registry
- NCT07870889, CTIS2026-525417-31-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Primary objective
- Primary endpoint
History
Study completion expected
Primary completion expected
Registered
Started