Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.

Detailed Description
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It was already demonstrated by previous clinical trials that statins lower the incidence of death and cardiovascular events in patients with coronary artery disease. However, whether aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients with coronary artery disease has not been studied in Japan.

Official Title
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Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Pitavastatin 1 mg daily or 4 mg daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who met following all criteria are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) Coronary artery disease patients meeting one of the following events History of Acute Coronary Syndrome (AMI or Unstable angina) History of revascularization (PCI or CABG) Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification Hypercholesterolemia patients meeting one of following criteria LDL-C is 140 mg/dL or over LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians Patents receiving cholesterol lowering drugs Age (≧20 <80 year-old) Patients given written informed consent. Exclusion Criteria: Exclusion Criteria(Pre-Run-in period) Patients planning revascularization Malignant tumor in active phase Patients who meet contraindication of LIVALO tablet below Patients who have hypersensitivity to LIVALO tablet Patients who have severe liver dysfunction or biliary atresia Patients who are being treated with cyclosporine Pregnant women, women suspected of being pregnant, or lactating women Patients who have heart failure NYHA III or greater Patients undergoing dialysis Patients with familial hypercholesterolemia Patients registered in the other clinical trials Patients taking prohibited drugs Patients who are ineligible in the opinion of the investigator Exclusion Criteria(Post-Run-in period) LDL-C is 120mg/dL or over after Run-in period Patients with occurrence of acute coronary syndrome (AMI or Unstable angina) within 3 months Patients who have been undergone PCI or CABG within 3 months Compliance is less than 50% in Run-in period Patients who met primary endpoint in Run-in period. Patients who met adverse events in Run-in period and judged as ineligible in the opinion of the investigator Patients who are ineligible in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pitavastatin 1 mg daily<br> | Drug: Pitavastatin 1 mg daily or 4 mg daily<br>* Patients who met all inclusion criteria and did not meet exclusion criteria (1) are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) After 1 month, patients who did not meet exclusion criteria(2) are randomized to take pitavastatin 1 mg/day or 4 mg/day.<br>* Other names: LIVALO Tablet;|
| Active Comparator: Pitavastatin 4 mg daily<br> | Drug: Pitavastatin 1 mg daily or 4 mg daily<br>* Patients who met all inclusion criteria and did not meet exclusion criteria (1) are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) After 1 month, patients who did not meet exclusion criteria(2) are randomized to take pitavastatin 1 mg/day or 4 mg/day.<br>* Other names: LIVALO Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization) |  | 3-6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite cardiovascular events |  | 3-6 years | 
| Composite coronary heart disease events |  | 3-6 years | 
| Composite cerebrovascular events |  | 3-6 years | 
| Death events |  | 3-6 years | 
| Heart disease events |  | 3-6 years | 
| Cerebrovascular events |  | 3-6 years | 
| The other events |  | 3-6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pitavastatin, Coronary Artery Disease, Cardiovascular Disease