Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
Information source: Juntendo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Pitavastatin 1 mg daily or 4 mg daily (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Katsumi Miyauchi Official(s) and/or principal investigator(s): Ryozou Nagai, MD, PhD, Principal Investigator, Affiliation: Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine Masunori Matsuzaki, MD, PhD, Principal Investigator, Affiliation: Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Overall contact: Shigeru Hayase, Phone: +81-3-5842-5051, Email: csp-ld@csp.or.jp
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.
Clinical Details
Official title: Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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: Composite cardiovascular eventsComposite coronary heart disease events Composite cerebrovascular events Death events Heart disease events Cerebrovascular events The other events
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
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
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
Locations and Contacts
Shigeru Hayase, Phone: +81-3-5842-5051, Email: csp-ld@csp.or.jp
Kyoto University Hospital, Kyoto 606-8507, Japan; Recruiting Takeshi Kimura, MD, Phone: +81-75-751-4254, Email: taketaka@kuhp.kyoto-u.ac.jp
Juntendo University School of Medicine, Tokyo, Japan; Recruiting Katsumi Miyauchi, MD, PhD, Phone: +81-3-3813-3111, Email: ktmmy@med.juntendo.ac.jp Ryozou Nagai, MD, PhD, Principal Investigator Masunori Matsuzaki, MD, PhD, Principal Investigator Hisao Ogawa, MD, PhD, Sub-Investigator Takeshi Kimura, MD, PhD, Sub-Investigator Hiroaki Shimokawa, MD, PhD, Sub-Investigator Hiroyuki Daida, MD, PhD, Sub-Investigator
Additional Information
Starting date: January 2010
Last updated: October 17, 2011
|