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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Pitavastatin 1 mg daily or 4 mg daily
Sponsored by
Juntendo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Pitavastatin, Coronary Artery Disease, Cardiovascular Disease

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyoto University Hospital
  • Juntendo University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pitavastatin 1 mg daily

Pitavastatin 4 mg daily

Arm Description

Outcomes

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)

Secondary Outcome Measures

Composite cardiovascular events
Composite coronary heart disease events
Composite cerebrovascular events
Death events
Heart disease events
Cerebrovascular events
The other events

Full Information

First Posted
January 5, 2010
Last Updated
May 14, 2021
Sponsor
Juntendo University
Collaborators
Tokyo University, Yamaguchi University Hospital, Tohoku University, Kyoto University, Kumamoto University
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1. Study Identification

Unique Protocol Identification Number
NCT01042730
Brief Title
Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
Official Title
Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Juntendo University
Collaborators
Tokyo University, Yamaguchi University Hospital, Tohoku University, Kyoto University, Kumamoto University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Pitavastatin, Coronary Artery Disease, Cardiovascular Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13054 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 1 mg daily
Arm Type
Active Comparator
Arm Title
Pitavastatin 4 mg daily
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pitavastatin 1 mg daily or 4 mg daily
Other Intervention Name(s)
LIVALO Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Composite cardiovascular events
Time Frame
3-6 years
Title
Composite coronary heart disease events
Time Frame
3-6 years
Title
Composite cerebrovascular events
Time Frame
3-6 years
Title
Death events
Time Frame
3-6 years
Title
Heart disease events
Time Frame
3-6 years
Title
Cerebrovascular events
Time Frame
3-6 years
Title
The other events
Time Frame
3-6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryozo Nagai, MD, PhD
Organizational Affiliation
Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Masunori Matsuzaki, MD, PhD
Organizational Affiliation
Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Juntendo University School of Medicine
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
36372869
Citation
Sakuma M, Iimuro S, Shinozaki T, Kimura T, Nakagawa Y, Ozaki Y, Iwata H, Miyauchi K, Daida H, Suwa S, Sakuma I, Nishihata Y, Saito Y, Ogawa H, Matsuzaki M, Ohashi Y, Taguchi I, Toyoda S, Inoue T, Nagai R. Optimal target of LDL cholesterol level for statin treatment: challenges to monotonic relationship with cardiovascular events. BMC Med. 2022 Nov 14;20(1):441. doi: 10.1186/s12916-022-02633-5.
Results Reference
derived
PubMed Identifier
29735587
Citation
Taguchi I, Iimuro S, Iwata H, Takashima H, Abe M, Amiya E, Ogawa T, Ozaki Y, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Miyauchi K, Yamazaki T, Ito H, Otsuji Y, Kimura K, Takahashi J, Hirayama A, Yokoi H, Kitagawa K, Urabe T, Okada Y, Terayama Y, Toyoda K, Nagao T, Matsumoto M, Ohashi Y, Kaneko T, Fujita R, Ohtsu H, Ogawa H, Daida H, Shimokawa H, Saito Y, Kimura T, Inoue T, Matsuzaki M, Nagai R. High-Dose Versus Low-Dose Pitavastatin in Japanese Patients With Stable Coronary Artery Disease (REAL-CAD): A Randomized Superiority Trial. Circulation. 2018 May 8;137(19):1997-2009. doi: 10.1161/CIRCULATIONAHA.117.032615. Erratum In: Circulation. 2019 Apr 2;139(14):e836.
Results Reference
derived

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

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