The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition
Occurrence of achieving ≥ 80% inhibition of FXI (\< 20% free FXI) following 3 months of treatment.
Time frame: month 3
number of patients achieving FXI inhibition ≥ 80% at trough after the first and second dose at 3 dose levels of MAA868
Occurrence of achieving ≥ 80% inhibition of FXI (\< 20% free FXI) at trough on Month 1 and Month 2
Time frame: Month 1 and 2
Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.
Incidence of major or clinically relevant non-major bleeding events
Time frame: day 1 to day 91
the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator
Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombin-antithrombin III-complexes (TAT), fibrinogen).
Time frame: Days 31, 61 and 91
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