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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Detailed Description

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.

Interventions

  • Drug: Pitavastatin 1 mg daily or 4 mg daily
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Pitavastatin 1 mg daily
  • Active Comparator: Pitavastatin 4 mg daily

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Composite cardiovascular events
    • Time Frame: 3-6 years
  • Composite coronary heart disease events
    • Time Frame: 3-6 years
  • Composite cerebrovascular events
    • Time Frame: 3-6 years
  • Death events
    • Time Frame: 3-6 years
  • Heart disease events
    • Time Frame: 3-6 years
  • Cerebrovascular events
    • Time Frame: 3-6 years
  • The other events
    • Time Frame: 3-6 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Juntendo University
  • Collaborator
    • Tokyo University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ryozo Nagai, MD, PhD, Principal Investigator, Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine
    • Masunori Matsuzaki, MD, PhD, Principal Investigator, Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

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