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

Sponsor

Otsuka Beijing Research Institute (Industry)

Overall Status

Completed

CT.gov ID

NCT00823875

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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 Names: Pletaal
Experimental: 2	Drug: Probucol group Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner Other Names: 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 Names: Pletaal and Changtai
Other: 4 Control Group	Drug: control group routine treatment Other Names: Routine Treatment

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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