Atherosclerosis Cerebral Infarction Clinical Trial
Official title:
A Randomized, Control, Open Label, Multicentre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject
Randomized, control, open label, multicentre clinical study. The patient who are in accordance with subject inclusion and exclusion criteria will be randomized to A group: Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment + Probucol; D group: Routine treatment+ Cilostazol+ Probucol .
Efficacy index:
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker
between 4 modality groups.
Pharmacokinetics:
After 12 weeks of treatment, the study medication plasma concentration including of Probucol
,Cilostazol , Cilostazol metabolism OPC-13015 and OPC-13213 will be measured.
Safety evaluation:
Analysis the abnormality of Adverse Event, Vital Sign, Physical Examination, 12-lead ECG,
and Laboratory Tests (including blood routine examination, routine urine analysis, blood
biochemistry examination, glycosylated hemoglobin) in 4 modality groups.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment