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

Purpose

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.

Condition	Intervention
Coronary Artery Disease	Drug: Pitavastatin 1 mg daily or 4 mg daily


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)

Resource links provided by NLM:

Drug Information available for: Pitavastatin

U.S. FDA Resources

Further study details as provided by Juntendo University Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite cardiovascular events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
Composite coronary heart disease events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
Composite cerebrovascular events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
Death events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
Heart disease events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
Cerebrovascular events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
The other events [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]


Estimated Enrollment:	12600
Study Start Date:	January 2010
Estimated Study Completion Date:	March 2017
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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


Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042730

Contacts


Contact: Shigeru Hayase	+81-3-5842-5051	csp-ld@csp.or.jp

Locations


Japan
Kyoto University Hospital	Recruiting
Kyoto, Japan, 606-8507
Contact: Takeshi Kimura, MD +81-75-751-4254 taketaka@kuhp.kyoto-u.ac.jp
Juntendo University School of Medicine	Recruiting
Tokyo, Japan
Contact: Katsumi Miyauchi, MD, PhD +81-3-3813-3111 ktmmy@med.juntendo.ac.jp
Principal Investigator: Ryozou Nagai, MD, PhD
Principal Investigator: Masunori Matsuzaki, MD, PhD
Sub-Investigator: Hisao Ogawa, MD, PhD
Sub-Investigator: Takeshi Kimura, MD, PhD
Sub-Investigator: Hiroaki Shimokawa, MD, PhD
Sub-Investigator: Hiroyuki Daida, MD, PhD

Sponsors and Collaborators

Katsumi Miyauchi

Tokyo University

Yamaguchi University Hospital

Tohoku University

Kyoto University

Kumamoto University

Investigators


Principal Investigator:	Ryozou 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

More Information

No publications provided


Responsible Party:	Katsumi Miyauchi, Juntendo University School of Medicine
ClinicalTrials.gov Identifier:	NCT01042730 History of Changes
Other Study ID Numbers:	CSP-LD-09
Study First Received:	January 5, 2010
Last Updated:	October 17, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Juntendo University Hospital:


Pitavastatin Coronary Artery Disease Cardiovascular Disease

Additional relevant MeSH terms:


Coronary Artery Disease Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases Pitavastatin	Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015