Health TrialsbyHealthPanel

Vortosiran in Atrial Fibrillation

ConditionNon-valvular Atrial Fibrillation (AF)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45+
SponsorRibocure Pharmaceuticals AB

About this trial

This is a randomised, actively controlled Phase IIb trial to evaluate the safety and pharmacodynamics (PD) of two blinded doses of subcutaneously administered vortosiran and open-label apixaban in patients with AF.

The trial consists of three groups including 50 participants each. The participants will be randomized to either the low dose group or the high dose group receiving vortosiran or to the group receiving apixaban. The treatment will be open-label for vortosiran vs apixaban. The vortosiran dose will be blinded to patients and investigators.

Both the low- and the high-dose group will receive two doses of vortosiran, the first dose at Day X and the second at Day Y. After 24 weeks, at the end of the vortosiran treatment period, the participants will start an open-label part of the trial and will be switched to standard-of-care apixaban treatment until Week 64 (End of Trial; EOT). Participants in the open-label apixaban arm will receive apixaban as standard of care during the entire trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Capable of giving signed informed consent. Written informed consent must be obtained before any trial procedure is initiated.

Age >/=55 years with >/=12 months of spontaneous amenorrhea, or

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vortosiran

    Drug

    Vortosiran, active drug

  • Vortosiran

    Drug

    Vortosiran, active drug

  • Apixaban

    Drug

    Comparator, active drug

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Low dose group receiving vortosiran.Active comparator 1 intervention
Group B: High dose group receiving vortosiran.Active comparator 1 intervention
Group C: Group receiving apixabanActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary objective

To evaluate the effect of vortosiran on change in coagulation Factor XI (FXI) activity

Time frame
At week 16
2

Primary endpoint

Change in FXI blood coagulation activity.

Time frame
At week 16

Secondary outcomes

1

Secondary objective

To evaluate the safety, including the frequency and severity of bleeding events, with vortosiran, when administered subcutaneously as repeated doses, in participants with non-valvular AF, when compared to apixaban.

Time frame
From screening until end of trial at week 64
2

Secondary objective

To evaluate the safety, including the frequency and severity of bleeding events, with vortosiran, when administered subcutaneously to patients concomitantly taking apixaban, in participants with AF

Time frame
From screening until end of trial at week 64
3

Secondary objective

Change in FXI blood coagulation activity

Time frame
At week 64
4

Secondary objective

To assess plasma exposure of vortosiran in participants with non-valvular AF

Time frame
0 (pre-dose) to 24 hours after dosing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ribocure Pharmaceuticals AB

Lead sponsor

LINK Medical Research AB

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: