Trials Sponsors Conditions Drugs Pricing

Conditions

non-valvular atrial fibrillation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Outcome Measures

Primary Outcomes (1)

Percentage change in FXI activity from baseline at Week 16.

Secondary Outcomes (7)

a) All bleeding events (including ISTH major, CRNM bleeding, and minor bleeding) during the treatment period.
b) AEs (including intensity and seriousness) during the trial, as well as clinically significant changes in laboratory parameters and vital signs.
c) Absolute and percentage change from baseline in FXI activity and FXI xx throughout the trial period, including intervals where subjects are receiving overlapping vortosiran and apixaban.
d) Plasma concentrations of vortosiran summarised by sampling collection time points.
e) Incidence of positive immunogenicity, measured as titre of ADAs, at each evaluation time point. (Only to be analysed if warranted based on emerging safety-, PK- or PD data)
+2 more secondary outcomes

Interventions

The corresponding placebo consist of the 25 mm phosphate buffer solution with 2 µg of vitamin b2 added for colouring purposes onlyType not reported

APIXABAN Type not reported

RBD4059 injectionType not reported

Eligibility Criteria

Sexall

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

You may qualify if:

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

Ribocure Pharmaceuticals AB
Industrylead

Study Sites (15)

Herlev Hospital

Herlev, 2730, Denmark

Adam Ali Holm Ghotbi+4522664446 adam.ali.holm.gothbi@regionh.dk

Region Hovedstaden

Frederiksberg, 2000, Denmark

Thomas Hermann+4524975687 thomas.steffen.hermann@regionh.dk

Sykehuset Oestfold HF Kalnes

Graalum, 1714, Norway

Ole-Christian Rutherford+4769860000

Central Study Contacts

Anna Pettersen

+46725821553 anna.pettersen@ribocure.com

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

April 10, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2026-525417-31-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:48:56 UTC

Documents

K1_Recruitment arrangements DK

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations