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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01042730
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : May 17, 2021
Sponsor:
Collaborators:
Tokyo University
Yamaguchi University Hospital
Tohoku University
Kyoto University
Kumamoto University
Information provided by (Responsible Party):
Juntendo University

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Pitavastatin 1 mg daily or 4 mg daily Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13054 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
Actual Study Start Date : February 2010
Actual Primary Completion Date : June 2016
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pitavastatin 1 mg daily 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 4 mg daily 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Composite cardiovascular events [ Time Frame: 3-6 years ]
  2. Composite coronary heart disease events [ Time Frame: 3-6 years ]
  3. Composite cerebrovascular events [ Time Frame: 3-6 years ]
  4. Death events [ Time Frame: 3-6 years ]
  5. Heart disease events [ Time Frame: 3-6 years ]
  6. Cerebrovascular events [ Time Frame: 3-6 years ]
  7. The other events [ Time Frame: 3-6 years ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042730


Locations
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Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Juntendo University School of Medicine
Tokyo, Japan
Sponsors and Collaborators
Juntendo University
Tokyo University
Yamaguchi University Hospital
Tohoku University
Kyoto University
Kumamoto University
Investigators
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Principal Investigator: Ryozo 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juntendo University
ClinicalTrials.gov Identifier: NCT01042730    
Other Study ID Numbers: CSP-LD-09
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Keywords provided by Juntendo University:
Pitavastatin
Coronary Artery Disease
Cardiovascular Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents