2026-525417-31-00RecruitingPhase 2
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Sept 2026
Brief summary (registry, in English)
a) To evaluate the effect of vortosiran on percent change from baseline in FXI activity at Week 16.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Apr 2026
- Start date
- 13 Oct 2026
- Lead sponsor
- Ribocure Pharmaceuticals AB
- Diseases
- Atrial fibrillation
- EU CT number
- 2026-525417-31-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- 15 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Women of childbearing potential (women are considered of childbearing potential if they are not surgically sterile or postmenopausal, defined as amenorrhea for > 12 months).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Hovedstaden | Frederiksberg | Denmark | Recruiting |
| Herlev Hospital | Herlev | Denmark | Recruiting |
| Sykehuset Oestfold HF Kalnes | Graalum | Norway | Not yet recruiting |
| Akershus University Hospital | Loerenskog | Norway | Not yet recruiting |
| Vitamedicum Itw Sp. z o.o. sp.k. | Cracow | Poland | Recruiting |
| EMC Silesia Sp. z o.o. | Katowice | Poland | Recruiting |
| Aidport sp z o.o. | Skorzewo | Poland | Recruiting |
| Lux-Med Sp. z o.o. | Warsaw | Poland | Recruiting |
| BALSAM MEDICA | Warszawa | Poland | Recruiting |
| Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. | Wroclaw | Poland | Recruiting |
| Centrum Medyczne Oporow | Wroclaw | Poland | Recruiting |
| PRACOWNIA BADAŃ KLINICZNYCH SALUS | Wrocław | Poland | Recruiting |
| Danderyds Sjukhus AB | Danderyd | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus | Lund | Sweden | Recruiting |
| Soedersjukhuset AB | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.