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

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

This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.

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.

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