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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
Coronary Artery Disease
Drug: Pitavastatin 1 mg daily or 4 mg daily

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)

Resource links provided by NLM:


Further study details as provided by Juntendo University Hospital:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12600
Study Start Date: January 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042730

Contacts
Contact: Shigeru Hayase +81-3-5842-5051 csp-ld@csp.or.jp

Locations
Japan
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Takeshi Kimura, MD    +81-75-751-4254    taketaka@kuhp.kyoto-u.ac.jp   
Juntendo University School of Medicine Recruiting
Tokyo, Japan
Contact: Katsumi Miyauchi, MD, PhD    +81-3-3813-3111    ktmmy@med.juntendo.ac.jp   
Principal Investigator: Ryozou Nagai, MD, PhD         
Principal Investigator: Masunori Matsuzaki, MD, PhD         
Sub-Investigator: Hisao Ogawa, MD, PhD         
Sub-Investigator: Takeshi Kimura, MD, PhD         
Sub-Investigator: Hiroaki Shimokawa, MD, PhD         
Sub-Investigator: Hiroyuki Daida, MD, PhD         
Sponsors and Collaborators
Katsumi Miyauchi
Tokyo University
Yamaguchi University Hospital
Tohoku University
Kyoto University
Kumamoto University
Investigators
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
  More Information

No publications provided

Responsible Party: Katsumi Miyauchi, Juntendo University School of Medicine
ClinicalTrials.gov Identifier: NCT01042730     History of Changes
Other Study ID Numbers: CSP-LD-09
Study First Received: January 5, 2010
Last Updated: October 17, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Juntendo University Hospital:
Pitavastatin
Coronary Artery Disease
Cardiovascular Disease

Additional relevant MeSH terms:
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
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014