Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease
- Registration Number
- NCT02607436
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sarpogrelate + Aspirin Aspirin Sarpogrelate as an active drug Aspirin alone Aspirin Aspirin as an active comparator Sarpogrelate + Aspirin Sarpogrelate Sarpogrelate as an active drug
- Primary Outcome Measures
Name Time Method Coronary artery disease assessed by cardiac computed tomography angiography 6 months
- Secondary Outcome Measures
Name Time Method 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 composition assessed by cardiac computed tomography angiography 6 months Changes of Ankle-branchial index 6 months Glucose metabolism assessed by glycated hemoglobin 6 months Changes of plaque size assessed by cardiac computed tomography angiography 6 months Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol 6 months Changes of pulse wave velocity 6 months
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of