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

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ClinicalTrials.gov Identifier: NCT00823875
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : December 1, 2010
Sponsor:
Information provided by:
Otsuka Beijing Research Institute

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Cilostazol

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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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823875


Locations
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China
First Affliate Hospital of Beijing University
Beijing, China
Sponsors and Collaborators
Otsuka Beijing Research Institute
Investigators
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Principal Investigator: Yining Huang, M.D. Peking University First Hospital
More Information
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Responsible Party: Quanjie Wei, Otsuka Beijing Research Institue
ClinicalTrials.gov Identifier: NCT00823875    
Other Study ID Numbers: 260-08-803-01
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Cerebral Infarction
Intracranial Arteriosclerosis
Atherosclerosis
Infarction
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