The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,280
Incidence of major and clinically relevant non-major bleeding events
Time frame: Double-blind treatment period (variable, up to 16 months)
Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths
Time frame: Double-blind treatment period (variable, up to 16 months)
Incidence of bleeding events
Time frame: Double-blind treatment period (variable, up to 16 months)
Assessment of other safety variables
Time frame: Double blind treatment period (variable, up to 16 months)
Assessment of PK/PD variables
Time frame: Double-blind treatment period (up to week 12)
Patient Reported Outcomes
Time frame: Double-blind treatment period (up to week 24)
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Auchenflower, Australia
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Caboolture, Australia
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Kippa-Ring, Australia
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Victoria, Australia
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Vienna, Austria
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Vienna, Austria
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Dimitrovgrad, Bulgaria
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Pleven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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