Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM

Study Overview
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Brief Summary
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This is a prospective interventional study to assess the effect of cilostazol compared with aspirin in Korean T2DM patients with atherosclerosis.

Detailed Description
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Type 2 diabetes has been increased exponentially, arousing serious economic, social and health repercussions. Also, macrovascular complications of diabetes such as myocardial infarct or stroke have been increased. Individuals with diabetes have a greater risk of cardiovascular disease (CVD), approximately two to four times than that of those without diabetes. Currently, the U.S. Food and Drug Administration requires demonstration that new anti-hyperglycemic agents do not increase CV risk. The comprehensive and multifactorial management in type 2 diabetes, which includes control of hypertension, dyslipidemia and obesity, is known to significantly reduce the risk of CVD as shown in Steno-2 study. However, most anti-diabetic agents currently used in clinical practice do not seem to provide enough CV protection. This is a prospective interventional study to assess the effect of cilostazol compared with aspirin in Korean T2DM patients with atherosclerosis. T2DM patients who have coronary artery stenosis by MDCT at least 3 months prior to this investigation will be enrolled. Considering drop out due to adverse events or follow up loss, sufficient patients will be enrolled. Their medical record will be reviewed and relevant clinical and laboratory findings will be collected. Cardiac computed tomography (CT) was introduced in the early 1990s. However, electron-beam CT (EBCT) only provided information on simple coronary artery calcium score (CAC). Recently, MDCT has been introduced, which can evaluate coronary arteries comprehensively. MDCT images can provide measurements of CAC, the degree of stenosis, and the characteristics of plaque including its potential vulnerability. These findings of MDCT have been reported to be in good agreement with intravascular ultrasound. All scans are analyzed independently by two experienced investigators using a 3D workstation, who are blinded to the clinical information (Brilliance; Philips Medical Systems). After independent evaluations are made, a consensus interpretation is arrived at regarding the final MDCT diagnosis. Each lesion is identified using a multiplanar reconstruction technique and maximum intensity projection of the short axis, in two-chamber and four-chamber views. Image quality is evaluated on a per-segment basis and classified. Plaque characteristics on a per-segment basis are analyzed according to the modified American Heart Association classification.

Official Title
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Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With Type 2 Diabetes Mellitus

Conditions
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Coronary Artery Disease

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 with HbA1c ≥ 6.0% at screening visit Male or female between 30 and 80 years of age Coronary artery stenosis: 25-75% without no evidence of acute coronary syndrome No history of previous myocardial infarction Estimated GFR ≥ 60 ml/min/1.73m² Exclusion Criteria: SBP/DBP> 160/110 Congestive heart failure Allegy to radiocontrast dye Allegy to aspirin or cilostazol Acute bleeding History of ulcer bleeding GOT/GPT > 100/100 Other antiplatlet medication

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 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: Cilostazol<br>Cilostazol 100-200 mg qd | Drug: Cilostazol<br>* Pletaal as an active drug<br>* Other names: Pletaal;|
| Active Comparator: Aspirin<br>Asprin 100mg qd for active comparator | Drug: Aspirin<br>* Aspirin as an active comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery stenosis | Severity of coronary artery stenosis (%) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque characteristics | Noncalified plaque | one year | 
| Plaque characteristics | Mixed plaque | one year | 
| Plaque characteristics | Calcified plaque | one year | 
| Multivessel involvement | Multivessel involvement in coronary arteries | one year | 
| Main vessel involvement | Left main and/or proximal LAD stenosis | one year | 
| Coronary artery calcium (CAC) score | Agatston score for CAC | one year | 
| Glucose homeostasis | Changes in HbA1c | one year | 
| Glucose homeostasis | Changes in fasting glucose concentration | one year | 
| Lipid metabolism | Changes in TG concentration | one year | 
| Lipid metabolism | Changes in HDL-concentration concentration | one year |