The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
536
DU-176b tablets taken once daily for up to 12 weeks
Warfarin potassium tablets taken once daily for up to 12 weeks
Unnamed facility
Tokyo, Japan
Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.
The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.
Time frame: 12 weeks
Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.
Time frame: 12 weeks
Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment
Time frame: 12 weeks
Pharmacodynamic Parameters (PT, PT-INR, and APTT)
PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time
Time frame: 12 weeks
Plasma DU-176 Concentration
Time frame: 12 weeks
Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )
Time frame: 12 weeks
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