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

NCT ID: NCT00823875

Last Updated: 2010-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-07-31

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Atherosclerosis Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Cilostazol group

Intervention Type 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.

2

Group Type EXPERIMENTAL

Probucol group

Intervention Type DRUG

Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner

3

Group Type EXPERIMENTAL

Cilostazol + Probucol group

Intervention Type 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

4

Control Group

Group Type OTHER

control group

Intervention Type DRUG

routine treatment

Interventions

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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.

Intervention Type DRUG

Probucol group

Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner

Intervention Type 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

Intervention Type DRUG

control group

routine treatment

Intervention Type DRUG

Other Intervention Names

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Pletaal Changtai Pletaal and Changtai Routine Treatment

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Otsuka Beijing Research Institue

Principal Investigators

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Yining Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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First Affliate Hospital of Beijing University

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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260-08-803-01

Identifier Type: -

Identifier Source: org_study_id