Atherosclerosis Cerebral Infarction
Conditions
Brief summary
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 .
Detailed description
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.
Interventions
DRUGCilostazol group
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.
DRUGProbucol group
Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
DRUGCilostazol + Probucol group
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
DRUGcontrol group
routine treatment
Sponsors
Otsuka Beijing Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 40～80-year-old male or female 2. By brain CT or MRI result, cerebral infarction is clarified diagnosis within 1 year 3. With atherosclerosis, atherosclerosis should meet at least one of the conditions as below: * Clarified diagnosis of type 2 diabetes before * Clarified diagnosis of primary hypertension before * Clarified diagnosis of Atherosclerotic stenosis in any 2 or more than 2 regions as cerebral artery, carotid, extremity artery and coronary by conformation of ultrasonic or angiography result 4. Has Aspirin regularly for more than 1 month before registration 5. Informed Consent Form signature
Exclusion criteria
： 1. Has an allergic history to study drugs( including of Probucol and Cilostazol) and Aspirin 2. Had lipid-lowing agents within the last 3 months ( except Statins) 3. Had antiplatelet or anticoagulation agents within the last 3 months (except Aspirin) 4. Had acute cerebral infarction within the last 1 month 5. Has cardiogenic cerebral embolism 6. At the registration ,Modified Rankin Scale ≥ 4 7. Hemorrhagic tendency or hemorrhagic disease (such as cerebral hemorrhage, gastrointestinal tract hemorrhage, etc.) 8. Had a myocardial infarction, angina pectoris within the last 3 months 9. Congestive heart failure 10. Is pregnant, is potentially pregnant, or is breastfeeding 11. Severe hepatic inadequacy or severe renal inadequacy (AST or ALT is 2.5 times higher than the upper limit of the normal value range, or serum creatinine is 1.2 times higher than the upper limit of the normal value range) 12. Persistent or hardly controlled hypertension (such as malignant hypertension, BP\> 160/100 mmHg) 13. Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions) 14. Has a medical history that includes a cardiac syncope or a primary syncope 15. Has a condition that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.) 16. Has severe diseases (such as, malignant tumor, severe anaemia, severe hematologic diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, etc.) 17. Registered other clinical trails within the last 3 months 18. Has vasculitis, moyamoya disease and other non-atherosclerosis vascular diseases 19. Other conditions that could exclude the subject from this study by doctor's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups. | 12 week |
Countries
China
Outcome results
None listed