A randomised active-controlled study to assess the safety and pharmacodynamics of two blinded doses of vortosiran and open-label apixaban in patients with non-valvular atrial fibrillation
Key facts
- Where
- Cracow, Katowice, Skorzewo, Warsaw, Warszawa, Wroclaw és Wrocław, LengyelországSee the 8 sites
- Phase
- 2. fázis
Where in Lengyelország
- Vitamedicum Itw Sp. z o.o. sp.k.Cracow, LengyelországTaking people
- EMC Silesia Sp. z o.o.Katowice, LengyelországTaking people
- Aidport sp z o.o.Skorzewo, LengyelországTaking people
- Lux-Med Sp. z o.o.Warsaw, LengyelországTaking people
- BALSAM MEDICAWarszawa, LengyelországTaking people
- Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.Wroclaw, LengyelországTaking people
- Centrum Medyczne OporowWroclaw, LengyelországTaking people
- PRACOWNIA BADAŃ KLINICZNYCH SALUSWrocław, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ribocure Pharmaceuticals AB
- Trial code
- EU 2026-525417-31-00
- Record updated
- 2026. szeptember 29.
- Original description
a) To evaluate the effect of vortosiran on percent change from baseline in FXI activity at Week 16.Read full original descriptionShow less
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
a) To evaluate the effect of vortosiran on percent change from baseline in FXI activity at Week 16.
Inclusion: Age ≥45 years; Documented diagnosis of non-valvular AF within 12 months of signing the informed consent (paroxysmal, persistent, or permanent) confirmed by ECG evidence (12-lead or other physician-confirmed electronic recording) and currently receiving continuous treatment with a DOAC for stroke prevention for at least the past 3 months; Capable of giving signed informed consent. Written informed consent must be obtained before any trial procedure is initiated.
Exclusion: Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral haemorrhage at any time in the absence of antithrombotic treatment; Any stroke within 14 days before randomisation or a transient ischemic attack within 3 days before randomisation; AF due to a reversible cause (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism, alcohol use), participants in sinus rhythm after successful ablation or planned for cardioversion or ablation during trial conduct; Women of childbearing potential (women are considered of childbearing potential if they are not surgically sterile or postmenopausal, defined as amenorrhea for > 12 months).