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| Name | Class |
|---|---|
| University of the Ryukyus | OTHER |
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The purpose of this study is to determine whether intensive blood pressure and low density lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in Japanese diabetic patients with coronary artery disease and history of acute coronary syndrome.
Prevalence of type 2 diabetes in Asia seems to be almost epidemic and establishment of preventive strategy against macrovascular as well as microvascular diseases are warranted because of higher cardiovascular risk in diabetic patients even without history of atherosclerotic cardiovascular diseases. Benefit of lowering low density lipoprotein (LDL) cholesterol down to 70 mg/ml in Caucasian patients with coronary artery disease (CAD) has been well established but not in Asian patients with lower risk of myocardial infarction and higher stroke risk. Intensive lowering blood pressure for cardiovascular outcome in diabetic patients and patients with CAD has been recommended in several guidelines without firm evidence. Risk and benefit of intensive blood pressure and LDL control should be evaluated in Japanese diabetic CAD patients by pragmatic randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive control | Active Comparator | systolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl |
|
| standard control | Active Comparator | systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive control | Other | use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite endpoint | composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration | 3 years |
| important secondary composite endpoint | composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | death due to any cause | 3 years |
| myocardial infarction | non fatal myocardial infarction | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shinichiro Ueda, MD, PhD | Professor of Clinical Pharmacology and Therapeutics, University of the Ryukyus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, University of the Ryukyus | Nishihara | Okinawa | 903-0215 | Japan | ||
| Saga University Hospital |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003324 | Coronary Artery Disease |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| standard control | Other | use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl |
|
| stroke | non fatal stroke excluding transient ischemic attack | 3 years |
| Cardiovascular death | Cardiovascular death | 3 years |
| end stage renal disease | end stage renal disease needs kidney transplantation or hemodialysis | 3 years |
| peripheral artery disease | peripheral artery disease | 3 years |
| new onset or deterioration of heart failure | new onset or deterioration of heart failure | 3 years |
| Saga |
| 849-8501 |
| Japan |
| D004700 | Endocrine System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |