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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042730
• Other study ID #: CSP-LD-09
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: November 2017

Study information

• Verified date: May 2021
• Source: Juntendo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13054
• Est. completion date: November 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto
Japan	Juntendo University School of Medicine	Tokyo

Sponsors (6)

Lead Sponsor	Collaborator
Juntendo University	Kumamoto University, Kyoto University, Tohoku University, Tokyo University, Yamaguchi University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization)		3-6 years
Secondary	Composite cardiovascular events		3-6 years
Secondary	Composite coronary heart disease events		3-6 years
Secondary	Composite cerebrovascular events		3-6 years
Secondary	Death events		3-6 years
Secondary	Heart disease events		3-6 years
Secondary	Cerebrovascular events		3-6 years
Secondary	The other events		3-6 years