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NOT YET RECRUITING
NCT07870889
PHASE2

Vortosiran in Atrial Fibrillation

Sponsor: Ribocure Pharmaceuticals AB

View on ClinicalTrials.gov

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

Interventions

DRUG

Vortosiran

Vortosiran, active drug

DRUG

Vortosiran

Vortosiran, active drug

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