Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
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ClinicalTrials.gov Identifier: NCT01042730 |
Recruitment Status :
Completed
First Posted : January 6, 2010
Last Update Posted : May 17, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Drug: Pitavastatin 1 mg daily or 4 mg daily | Not Applicable |
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 |

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 |
- 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 ]
- 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 ]

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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 |
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

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
Japan | |
Kyoto University Hospital | |
Kyoto, Japan, 606-8507 | |
Juntendo University School of Medicine | |
Tokyo, Japan |
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 |
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 |
Pitavastatin Coronary Artery Disease Cardiovascular Disease |
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 |