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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Other | Control Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol group | Drug | Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg(2 tablets)Bid. |
| Measure | Description | Time Frame |
|---|---|---|
| After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups. | 12 week |
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Inclusion Criteria:
40~80-year-old male or female
By brain CT or MRI result, cerebral infarction is clarified diagnosis within 1 year
With atherosclerosis, atherosclerosis should meet at least one of the conditions as below:
Has Aspirin regularly for more than 1 month before registration
Informed Consent Form signature
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yining Huang, M.D. | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affliate Hospital of Beijing University | Beijing | China |
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|
| Probucol group | Drug | Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner |
|
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| Cilostazol + Probucol group | Drug | Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg(2 tablets)Bid. Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner |
|
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| control group | Drug | routine treatment |
|
|
| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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