Trials Sponsors Conditions Drugs Pricing

Conditions

Non-valvular Atrial Fibrillation (AF)

Keywords

AFAtrial fibrillationsiRNAPhase 2RCT

Outcome Measures

Primary Outcomes (2)

Primary objective
To evaluate the effect of vortosiran on change in coagulation Factor XI (FXI) activity
At week 16
Primary endpoint
Change in FXI blood coagulation activity.
At week 16

Secondary Outcomes (7)

Secondary objective
From screening until end of trial at week 64
Secondary objective
From screening until end of trial at week 64
Secondary objective
At week 64
Secondary objective
0 (pre-dose) to 24 hours after dosing
Secondary objective
At week 64
+2 more secondary outcomes

Study Arms (3)

Low dose group receiving vortosiran.

ACTIVE COMPARATOR

The low-dose group will receive two doses of vortosiran, the first dose at Day X and the second at Day Y. After 24 weeks, the participants will start an open-label part of the trial and receive apixaban until the end of the trial.

Drug: Vortosiran

High dose group receiving vortosiran.

ACTIVE COMPARATOR

Drug: Vortosiran

Group receiving apixaban

ACTIVE COMPARATOR

Interventions

VortosiranDrug

Vortosiran, active drug

Low dose group receiving vortosiran.

VortosiranDrug

Vortosiran, active drug

High dose group receiving vortosiran.

Eligibility Criteria

Age45 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult male and female participants, 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.

Sponsors & Collaborators

Link Medical Research AB
Industrycollaborator
Ribocure Pharmaceuticals AB
Industrylead

Study Sites (15)

Frederiksberg Hospital

Frederiksberg, Denmark

Thomas Hermann, DoctorCONTACT

Thomas Hermann, DoctorPRINCIPAL INVESTIGATOR

Herlev-Gentofte

Herlev, Denmark

Adam Ali Ghotbi, DoctorCONTACTadam.ali.holm.ghotbi@regionh.dk

Adam Ali Ghotbi, DoctorPRINCIPAL INVESTIGATOR

Sykehuset Østfold Kalnes Kardiologisk

Grålum, Norway

Ole-Christian Rutherford, DoctorCONTACTole-christian.rutherford@so-hf.no

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Anders Gabrielsen, MD, PhD
Ribocure Pharmaceuticals
STUDY DIRECTOR

Central Study Contacts

Rebeckha Magnusson, Head Clinical Operations

CONTACT

+46 31 72 07 800 rebeckha.magnusson@ribocure.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 29, 2026

First Posted

October 13, 2026

Study Start

You may not qualify if:

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.
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.
Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or trans vascular) during the course of the trial.
Patients with a medical condition other than non-valvular AF for which chronic anticoagulation is indicated.
Known presence of an atrial myxoma or left ventricular thrombus.
History of or planned left atrial appendage closure or left atrial appendage removal.
Uncontrolled hypertension (systolic blood pressure \>/= 160 mmHg or diastolic blood pressure \>/=100 mmHg) at randomization.
Active bleeding, known bleeding disorder, or known anaemia that requires treatment or capillary Hgb \<100 g/L.
Any history of non-traumatic intracranial haemorrhage when not under treatment with an anticoagulant.
Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or hepatic insufficiency classified as Child-Pugh B or C, or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>2.5 x the upper limit of normal, measured between screening and randomisation.
Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 from the local lab, determined between screening and randomization.
Major surgery during the last 30 days or planned major surgery or intervention with potential for uncontrolled bleeding within the trial period (e.g., carotid endarterectomy, coronary artery bypass grafting).
Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post-treatment period are not eligible.
Known allergy, intolerance, or hypersensitivity to any of the trial interventions.
+8 more criteria

Vortosiran in Atrial Fibrillation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (3)

Low dose group receiving vortosiran.

High dose group receiving vortosiran.

Group receiving apixaban

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (3)

Low dose group receiving vortosiran.

High dose group receiving vortosiran.

Group receiving apixaban

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations