This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,146
30mg tablet once daily
60mg tablet once daily
30mg tablet two times a day
Adjudicated Incidence of Bleeding Events
Adjudicated Incidence of Bleeding Events during treatment period
Time frame: 3 months
Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)
liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities
Time frame: 3 months
Incidence of Major Adverse Cardiac Events MACE)
MACE is defined as the composite of stroke \[ischemic or hemorrhagic\], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition
Time frame: 3 months
Effects on Biomarker D-dimer
Mean (SD) change from baseline in D-dimer
Time frame: 3 months
Effects on Biomarker Prothrombin Fragments
Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)
Time frame: 3 months
Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b
Median (min, max) values of Cmin,ss; Cmax,ss
Time frame: 3 months
Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b
Median (min, max) values of AUCss
Time frame: 3 months
Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b
Mean (SD) change from baseline in biomarker anti-Factor Xa \[FXa\] activity on Day 28, 1-3 hours post dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
60mg tablet two times a day
warfarin tablets
Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Stockton, California, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Sarasota, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Canton, Georgia, United States
Unnamed facility
Fort Wayne, Indiana, United States
Unnamed facility
Iowa City, Iowa, United States
...and 81 more locations
Time frame: Day 28
Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b
Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.
Time frame: Day 28
Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b
Mean (SD) change from baseline in biomarker prothrombinase induced clotting time \[PICT\] on Day 28, 1-3 hours post dose. PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition.
Time frame: Day 28
Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b
Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.
Time frame: Day 28
Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b
Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.
Time frame: Day 28