The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Oral tablets; once daily for 60 days.
Oral tablets; once daily for 60 days
oral tablets; once daily for 60 days
Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis.
Time frame: Up to Day 121
Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events
Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages \<10 mm evident on magnetic resonance imaging \[MRI\]), clinical over signs of hemorrhge associated with a drop in hemoglobin \>=5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in a hemoglobin drop of 3 to \<5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding.
Time frame: Up to Day 60
Number of Participants With MACE or Death
The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization.
Time frame: Up to Day 121
Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit
Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden.
Time frame: Up to Day 60
Mean CD40 Ligand Levels By Study Visit
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oral tablets; once daily for 60 days
Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk.
Time frame: Up to Day 60
Mean Membrane-Bound P-Selectin Levels By Study Visit
Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels.
Time frame: Up to Day 60