Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject
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ClinicalTrials.gov Identifier: NCT00823875 |
Recruitment Status :
Completed
First Posted : January 16, 2009
Last Update Posted : December 1, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerosis Cerebral Infarction | Drug: Cilostazol group Drug: Probucol group Drug: Cilostazol + Probucol group Drug: control group | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Cilostazol 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.
Other Name: Pletaal |
Experimental: 2 |
Drug: Probucol group
Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
Other Name: Changtai |
Experimental: 3 |
Drug: Cilostazol + 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 Other Name: Pletaal and Changtai |
4
Control Group
|
Drug: control group
routine treatment
Other Name: Routine Treatment |
- After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups. [ Time Frame: 12 week ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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
- Has Aspirin regularly for more than 1 month before registration
- Informed Consent Form signature
Exclusion criteria:
- Has an allergic history to study drugs( including of Probucol and Cilostazol) and Aspirin
- Had lipid-lowing agents within the last 3 months ( except Statins)
- Had antiplatelet or anticoagulation agents within the last 3 months (except Aspirin)
- Had acute cerebral infarction within the last 1 month
- Has cardiogenic cerebral embolism
- At the registration ,Modified Rankin Scale ≥ 4
- Hemorrhagic tendency or hemorrhagic disease (such as cerebral hemorrhage, gastrointestinal tract hemorrhage, etc.)
- Had a myocardial infarction, angina pectoris within the last 3 months
- Congestive heart failure
- Is pregnant, is potentially pregnant, or is breastfeeding
- 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)
- Persistent or hardly controlled hypertension (such as malignant hypertension, BP> 160/100 mmHg)
- Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
- Has a medical history that includes a cardiac syncope or a primary syncope
- Has a condition that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
- Has severe diseases (such as, malignant tumor, severe anaemia, severe hematologic diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, etc.)
- Registered other clinical trails within the last 3 months
- Has vasculitis, moyamoya disease and other non-atherosclerosis vascular diseases
- Other conditions that could exclude the subject from this study by doctor's judgment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823875
China | |
First Affliate Hospital of Beijing University | |
Beijing, China |
Principal Investigator: | Yining Huang, M.D. | Peking University First Hospital |
Responsible Party: | Quanjie Wei, Otsuka Beijing Research Institue |
ClinicalTrials.gov Identifier: | NCT00823875 |
Other Study ID Numbers: |
260-08-803-01 |
First Posted: | January 16, 2009 Key Record Dates |
Last Update Posted: | December 1, 2010 |
Last Verified: | January 2010 |
Cerebral Infarction Intracranial Arteriosclerosis Atherosclerosis Infarction Ischemia Pathologic Processes Necrosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Stroke Intracranial Arterial Diseases Cilostazol Probucol Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |