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

Conditions

non-valvular atrial fibrillation

Brief summary

Percentage change in FXI activity from baseline at Week 16.

Detailed description

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), f) Change from baseline in APTT and PT/INR levels throughout the trial period., g) Absolute and percentage change xx.

Related papers

No related papers found yet.

Interventions

DRUGAPIXABAN

DRUGRBD4059 injection

DRUGThe corresponding placebo consist of the 25 mm phosphate buffer solution with 2 µg of vitamin b2 added for colouring purposes only

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage change in FXI activity from baseline at Week 16.	—

Secondary

Measure	Time frame
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), f) Change from baseline in APTT and PT/INR levels throughout the trial period., g) Absolute and percentage change xx.	—

Measure

Time frame

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), f) Change from baseline in APTT and PT/INR levels throughout the trial period., g) Absolute and percentage change xx.

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Outcome results

None listed