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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarpogrelate + Aspirin | Experimental | Sarpogrelate as an active drug |
|
| Aspirin alone | Active Comparator | Aspirin as an active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarpogrelate | Drug | Sarpogrelate |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Coronary artery disease assessed by cardiac computed tomography angiography | 6 months |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo Lim, MD, PhD | SNUBH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C064294 | sarpogrelate |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin | Drug | Aspirin |
|
|
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |