Coronary Artery Disease
Conditions
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.
Interventions
DRUGSarpogrelate
Sarpogrelate
DRUGAspirin
Aspirin
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coronary artery disease assessed by cardiac computed tomography angiography | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Coronary artery calcium score assessed by cardiac computed tomography angiography | 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 |
| Changes of Ankle-branchial index | 6 months |
Countries
South Korea
Outcome results
None listed