Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease

Study Overview
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Brief Summary
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This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic 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 cardiovascular 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 cardiovascular protection.

Official Title
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Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Sarpogrelate
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes with HbA1c ≥ 6.5% at screening visit Male or female between 30 and 80 years of age Coronary artery stenosis: 10-75% without no evidence of acute coronary syndrome No history of previous myocardial infarction Exclusion Criteria: Systolic blood pressure / diastolic blood pressure > 160/110 mmHg Congestive heart failure Allergy to radiocontrast dye Allergy to aspirin or sarpogrelate Acute bleeding History of ulcer bleeding GOT/GPT > 100/100 Other antiplatelet 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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Accepts Healthy Volunteers

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: Sarpogrelate + Aspirin<br>Sarpogrelate as an active drug | Drug: Sarpogrelate<br>* Sarpogrelate<br>* Other names: Anplag;Drug: Aspirin<br>* Aspirin<br>* Other names: Aspirin protect or Astrix;|
| Active Comparator: Aspirin alone<br>Aspirin as an active comparator | Drug: Aspirin<br>* Aspirin<br>* Other names: Aspirin protect or Astrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery disease assessed by cardiac computed tomography angiography |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery calcium score assessed by cardiac computed tomography angiography |  | 6 months | 
| Coronary artery stenosis assessed by cardiac computed tomography angiography |  | 6 months | 
| Changes of plaque size assessed by cardiac computed tomography angiography |  | 6 months | 
| Changes of plaque composition assessed by cardiac computed tomography angiography |  | 6 months | 
| Changes of Ankle-branchial index |  | 6 months | 
| Changes of pulse wave velocity |  | 6 months | 
| Glucose metabolism assessed by glycated hemoglobin |  | 6 months | 
| Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol |  | 6 months |