Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

Study Overview
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Brief Summary
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This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes Mellitus (DM) patients.

Official Title
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Multi-Center, Randomized, Open Label Study of the Efficacy of Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events With Korean Type 2 DM Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Cilostazol
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus with high risk of macrovascular complications; high risk is one or more as follows: Hypertension (≧ 140/90 or anti-hypertensive therapy) Hypercholesterolemia (LDL-C > 130 mg/dL or anti-hyperlipidemic therapy) TG > 200 mg/dL Non proliferative retinopathy or macular edema Microalbuminuria or macroalbuminuria Smoker Patients on no anti PLT drug history Patients who are agree with this research Exclusion Criteria: Type 1 diabetes mellitus Macrovascular complication history Uncontrolled hypertension, unstable angina history Congestive heart failure Bleeding tendency Chronic liver disease (ALT > 100 or AST > 100) or Chronic renal disease creatinine > 3.0 mg/dl) Anemia (hemoglobin < 10 mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3) Pregnant or lactation women Plan to be revascularized in 4 weeks Plan to go to surgery or invasive intervention in 4 weeks Plan to need to admission for acute cardiovascular disease in 4 weeks Contraindication of this medication Other anti-PLT drug therapy

Ages Eligible for Study
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Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br>Aspirin 100 mg once a day | Drug: Aspirin<br>* 100 mg once a day<br>|
| Active Comparator: Cilostazol<br>Cilostazol 200 mg (50 mg 2T twice per day) | Drug: Cilostazol<br>* Cilostazol 200 mg (50 mg 2T twice per day)<br>* Other names: Pletaal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group |  | every 6 months following randomization, for 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Events of the ischemic heart disease |  | every 12 months following randomization, for 48 months | 
| Events of cerebrovascular disease |  | every 12 months following randomization, for 48 months | 
| Events of peripheral vascular disease |  | every 12 months following randomization, for 48 months | 
| Events of hemorrhagic vascular complication |  | every 12 months following randomization, for 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cilostazol versus Aspirin, Anti-PLT drug, Primary Prevention of Atherosclerotic Events, Type 2 DM, Intima media thickness (IMT)