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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 events

Composite 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

Page last updated: August 23, 2015

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