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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juntendo University; Katsumi Miyauchi
• Collaborators: Kumamoto University; Kyoto University; Tohoku University; Tokyo University; Yamaguchi University Hospital
• Treatments: Pitavastatin

Criteria

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