Under construction – not a live service
Sign in
Taking people in DenmarkPhase 2

Vortosiran compared with apixaban in people with non-valvular atrial fibrillation

Compares vortosiran with apixaban in adults with non-valvular atrial fibrillation.

Key facts

Who runs it
Ribocure Pharmaceuticals AB
Where
Frederiksberg and Herlev, DenmarkSee the 2 sitesAlso in 3 other countries, 13 sites
Trial code
Registry title
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
Status
Recruiting
Phase
Phase 2
People taking part
150 people, planned
Started
13 Oct 2026
Expected to end
31 Jul 2028
Type of study
Interventional
Record updated
29 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 45 or older with non-valvular atrial fibrillation who already take a DOAC blood thinner to prevent stroke.

Age
45 years or older.
Sex
All sexes can join.
Disease stage
Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) diagnosed within 12 months before consent and confirmed by ECG.
Earlier treatment
Must have been on continuous treatment with a DOAC for stroke prevention for at least the past 3 months.

Main reasons for not taking part

  • Women who could still become pregnant
  • Atrial fibrillation due to a reversible cause, or planned cardioversion or ablation during the trial
  • Bleeding inside the skull or eye in the 3 months before screening
  • Any history of spontaneous bleeding in the brain without blood-thinning treatment
  • Stroke within 14 days or transient ischemic attack within 3 days before randomisation

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Denmark

Also in 3 other countries, 13 sites

  • Region HovedstadenFrederiksberg, DenmarkTaking people
  • Herlev HospitalHerlev, DenmarkTaking people

About the trial

What the trial wants to find out

a) To evaluate the effect of vortosiran on percent change from baseline in FXI activity at Week 16.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
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
Plain-language title
Vortosiran compared with apixaban in people with non-valvular atrial fibrillationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
29 September 2026