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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Pitavastatin 1 mg daily or 4 mg daily

• Registration Number: NCT01042730
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Study Start: 2010-02
• Primary Completion: 2016-06
• Study Completion: 2017-11
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13054

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 1 mg daily	Pitavastatin 1 mg daily or 4 mg daily	-
Pitavastatin 4 mg daily	Pitavastatin 1 mg daily or 4 mg daily	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Composite coronary heart disease events	3-6 years
Composite cardiovascular events	3-6 years
The other events	3-6 years
Death events	3-6 years
Heart disease events	3-6 years
Composite cerebrovascular events	3-6 years
Cerebrovascular events	3-6 years

Trial Locations

Locations (2)

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

Juntendo University School of Medicine; 🇯🇵 Tokyo, Japan