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

This study is currently recruiting participants.
Verified October 2011 by Juntendo University Hospital
Sponsor:
Collaborators:
Tokyo University
Yamaguchi University Hospital
Tohoku University
Kyoto University
Kumamoto University
Information provided by (Responsible Party):
Katsumi Miyauchi, Juntendo University School of Medicine
ClinicalTrials.gov Identifier:
NCT01042730
First received: January 5, 2010
Last updated: October 17, 2011
Last verified: October 2011
History of Changes

January 5, 2010
October 17, 2011
January 2010
March 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  • Unstable angina requiring urgent hospitalization [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • Occurrence of one of following events: Cardiovascular death [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • Non-fatal Myocardial Infarction (MI) [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • Non-fatal Cerebral Infarction (CI) [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01042730 on ClinicalTrials.gov Archive Site
  • Composite cardiovascular events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
  • Composite coronary heart disease events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
  • Composite cerebrovascular events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
  • Death events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
  • Heart disease events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
  • Cerebrovascular events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
  • The other events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
  • Composite cardiovascular events [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • Composite coronary heart disease events [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • Composite cerebrovascular events [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • Death events [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • Heart disease events [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • Cerebrovascular events [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • The other events [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Coronary Artery Disease
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.
Other Name: LIVALO Tablet
  • Active Comparator: Pitavastatin 1 mg daily
    Intervention: Drug: Pitavastatin 1 mg daily or 4 mg daily
  • Active Comparator: Pitavastatin 4 mg daily
    Intervention: Drug: Pitavastatin 1 mg daily or 4 mg daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12600
March 2017
March 2016   (final data collection date for primary outcome measure)

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
Both
20 Years to 79 Years
No
Contact: Shigeru Hayase +81-3-5842-5051 csp-ld@csp.or.jp
Japan
 
NCT01042730
CSP-LD-09
Yes
Katsumi Miyauchi, Juntendo University School of Medicine
Katsumi Miyauchi
  • Tokyo University
  • Yamaguchi University Hospital
  • Tohoku University
  • Kyoto University
  • Kumamoto University
Principal Investigator: Ryozou Nagai, MD, PhD Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine
Principal Investigator: Masunori Matsuzaki, MD, PhD Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Juntendo University Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP