Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker

Study Overview
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Brief Summary
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To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker

Detailed Description
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Efficacy evaluation: Primary efficacy index: After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information Secondary efficacy index: After 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information Safety evaluation: Adverse Event Vital Sign and Physical Examination 12-lead ECG Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Arteriosclerosis Obliterans

Intervention / Treatment
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* Drug: Cilostazol
* Drug: Probucol
* Drug: Cilostazol+Probucol
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 75-year-old male or female Clarified diagnosis of type 2 diabetes mellitus Arteriosclerosis obliterans (ASO) is diagnosed (ASO diagnoses should meet at least one of the conditions as below: ABI<1.0; The pulse of popliteal artery or dorsalis pedis artery is weeken significantly or is different between left and right sides Intermittent claudication, diagnosed as ASO by doctor Ultrasonogram showed that there was atherosclerotic plaque in lower limb within 1 year Informed Consent Form Signature Exclusion Criteria: Has an allergic history to study drugs Use one of the following drugs: other antiplatelet or anticoagulation agents except Aspirin, other hypolipidemic agents except Statins Type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetes mellitus Has severe ASO above Fontaine IIb, Hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tract hemorrhage, etc.) Had a myocardial infarction, angina pectoris, or cerebral infarction within the last 3 months Congestive heart failure Is pregnant, or potentially pregnant, or breastfeeding Severe hepatic insufficient or severe renal insufficiency (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 conditions that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.) Has severe complications (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.) Other conditions that would exclude the subject from this study by doctor's judgement

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Cilostazol<br>* From 50mg, Bid, PO after breakfast and dinner. After 1-week of administration, if no significant study drug related discomfort, the dose can increase to 100mg, Bid, PO. Otherwise, remain at the 50 mg level.<br>* Other names: pletaal;|
| Experimental: 2<br> | Drug: Probucol<br>* 250 mg Bid, PO after breakfast and dinner.<br>* Other names: Changtai;|
| Experimental: 3<br> | Drug: Cilostazol+Probucol<br> <br> * Other names: Pletaal and Changtai;|
| No Intervention: 4<br>Control Group | Other: Control Group<br>* Routine treatment<br>* Other names: Routine treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, with Arteriosclerosis obliterans