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

Primary Purpose

Atherosclerosis Cerebral Infarction

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Cilostazol group

Probucol group

Cilostazol + Probucol group

control group

About this trial

This is an interventional treatment trial for Atherosclerosis Cerebral Infarction

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

First Affliate Hospital of Beijing University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Arm Label

Arm Description

Control Group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00823875

First Posted

January 15, 2009

Last Updated

November 30, 2010

Sponsor

Otsuka Beijing Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00823875

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Otsuka Beijing Research Institute

4. Oversight

Data Monitoring Committee

5. 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 .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis Cerebral Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Other

Arm Description

Control Group

Intervention Type

Drug

Intervention Name(s)

Cilostazol group

Other Intervention Name(s)

Pletaal

Intervention Description

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

Intervention Name(s)

Probucol group

Other Intervention Name(s)

Changtai

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cilostazol + Probucol group

Other Intervention Name(s)

Pletaal and Changtai

Intervention Description

Intervention Type

Drug

Intervention Name(s)

control group

Other Intervention Name(s)

Routine Treatment

Intervention Description

routine treatment

Primary Outcome Measure Information:

Title

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

Time Frame

12 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yining Huang, M.D.

Organizational Affiliation

Peking University First Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affliate Hospital of Beijing University

City

Beijing

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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