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

NCT00823875 | Completed Phase 4

• 1 other identifier: 260-08-803-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 .

Conditions

Atherosclerosis Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

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

  12 week

Study Arms (4)

1

EXPERIMENTAL

Drug: Cilostazol group

2

EXPERIMENTAL

Drug: Probucol group

3

EXPERIMENTAL

Drug: Cilostazol + Probucol group

4

OTHER

Control Group

Drug: control group

Interventions

Cilostazol group 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.

Also known as: Pletaal

1

Probucol group DRUG

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

Also known as: Changtai

2

Cilostazol + Probucol group 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

Also known as: Pletaal and Changtai

3

control group DRUG

routine treatment

Also known as: Routine Treatment

4

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ～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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

First Affliate Hospital of Beijing University

Beijing, China

Location

MeSH Terms

Interventions

Cilostazol; Control Groups

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yining Huang, M.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: December 1, 2010

Record last verified: 2010-01

Locations

CN (1)