Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject

Study Description

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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 .

Condition or disease	Intervention/treatment	Phase
Atherosclerosis Cerebral Infarction	Drug: Cilostazol group; Drug: Probucol group; Drug: Cilostazol + Probucol group; Drug: control group	Phase 4

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.

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups. [ Time Frame: 12 week ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

China
First Affliate Hospital of Beijing University
Beijing, China

Sponsors and Collaborators

Otsuka Beijing Research Institute

Investigators

Principal Investigator:	Yining Huang, M.D.	Peking University First Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Quanjie Wei, Otsuka Beijing Research Institue
ClinicalTrials.gov Identifier:	NCT00823875 History of Changes
Other Study ID Numbers:	260-08-803-01
First Posted:	January 16, 2009
Last Update Posted:	December 1, 2010
Last Verified:	January 2010

Additional relevant MeSH terms:

Infarction; Atherosclerosis; Cerebral Infarction; Intracranial Arteriosclerosis; 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