Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intensive Blood Pressure and LDL Lowering for Better Survival and Cardiovascular Outcome in Diabetic Patients With Coronary Artery Disease: Randomized Controlled Trial

Conditions
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Type 2 Diabetes, Coronary Artery Disease, Hypertension, Dyslipidemia

Intervention / Treatment
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* Other: intensive control
* Other: standard control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic patients with coronary artery disease and history of acute coronary syndrome Patients whose blood pressure and LDL cholesterol levels are above values recommended by the current guideline Exclusion Criteria: Patients who have active malignant tumor Patients who are on hemodialysis due to end stage kidney disease Patients whom statins are contraindicated Patients who had acute coronary syndrome or stroke within 3 months Patients who are pregnant or on breast feeding Patients whose physicians deem that attending this trial is contraindicated or inappropriate

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intensive control<br>systolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl | Other: intensive control<br>* use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl<br>|
| Active Comparator: standard control<br>systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl | Other: standard control<br>* use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | death due to any cause | 3 years | 
| myocardial infarction | non fatal myocardial infarction | 3 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, coronary artery disease, hypertension, dyslipidemia