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| Name | Class |
|---|---|
| Samjin Pharmaceutical Co., Ltd. | INDUSTRY |
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Diabetes is an increasing cause of atherosclerotic and cardiovascular illnesses in South Korea. The clinical application of ultrasound for measuring carotid intima-media thickness, which helps in early detection and surveillance of atherosclerosis, is advancing. Due to lifestyle changes and an aging population, Koreans, especially diabetics, are developing more vascular diseases and are at higher risk for peripheral vascular disorders. Diabetics with lower limb peripheral artery disease require effective therapy to avoid major complications and a reduced quality of life. Although licensed for symptom control, Clopidogrel and Cilostazol have not yet been established for primary prevention of cardiovascular risks. These medications will be evaluated for their potential as primary preventive agents against cardiovascular disease in type 2 diabetes patients. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and to evaluate their influence on hemorheological changes in individuals with Type 2 diabetes. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and evaluating their influence on alterations in blood flow among individuals with Type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel | Experimental | Clopidogrel 75mg once daily |
|
| Cilostazol | Active Comparator | Cilostazol 200mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Clopidogrel 75mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of carotid intima-media thickness | mm | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of circulation | measured by ankle brachial index and laser doppler | 52 weeks |
| Changes of HbA1c | % | 26 and 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Individuals currently using antithrombotic or anticoagulant medications other than aspirin
Individuals with bleeding or conditions that may increase the risk of bleeding, such as:
Patients who have had cerebrovascular or cardiovascular complications within the past 6 months (including stroke, transient ischemic attacks, myocardial infarction, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention)
Patients with severe renal or hepatic diseases
Patients with congestive heart failure
Individuals with a history of hypersensitivity to the drug or its components
Pregnant women or women who may be pregnant
Women who are breastfeeding or plan to breastfeed during the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Lim, MD. Ph.D. | Contact | +82317877035 | limsoo@snu.ac.kr | |
| Minji Sohn, Ph.D. | Contact | +82317878443 | rainbowmjs@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Soo Lim, MD. Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Cilostazol | Drug | Cilostazol 200mg per day |
|
|
| Changes of glucose | mg/dL | 26 and 52 weeks |
| Changes of body weight | kg | 26 and 52 weeks |
| Changes of whole body fat | measured by bioelectrical impedance analysis | 26 and 52 weeks |
| Changes of blood pressures | systolic, diastolic (mmHg) | 26 and 52 weeks |
| Changes of lipids | total cholesterol, triglycerides, LDLc, HDLc (mg/dL) | 26 and 52 weeks |
| Changes of peripheral pain or ischemic symptoms | measured by questionnaires (visual analogue scale: 100) | 26 and 52 weeks |
| Changes of laboratory values related to blood clot | prothrombin time, activated partial thromboplastin time | 26 and 52 weeks |
| D004700 | Endocrine System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D011804 | Quinolines |