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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: Pitavastatin 1 mg daily or 4 mg daily	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	12600 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
Study Start Date :	January 2010
Estimated Primary Completion Date :	March 2016
Estimated Study Completion Date :	March 2017

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Composite cardiovascular events [ Time Frame: 3-6 years ]
2. Composite coronary heart disease events [ Time Frame: 3-6 years ]
3. Composite cerebrovascular events [ Time Frame: 3-6 years ]
4. Death events [ Time Frame: 3-6 years ]
5. Heart disease events [ Time Frame: 3-6 years ]
6. Cerebrovascular events [ Time Frame: 3-6 years ]
7. The other events [ Time Frame: 3-6 years ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taguchi I, Iimuro S, Iwata H, Takashima H, Abe M, Amiya E, Ogawa T, Ozaki Y, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Miyauchi K, Yamazaki T, Ito H, Otsuji Y, Kimura K, Takahashi J, Hirayama A, Yokoi H, Kitagawa K, Urabe T, Okada Y, Terayama Y, Toyoda K, Nagao T, Matsumoto M, Ohashi Y, Kaneko T, Fujita R, Ohtsu H, Ogawa H, Daida H, Shimokawa H, Saito Y, Kimura T, Inoue T, Matsuzaki M, Nagai R. High-Dose Versus Low-Dose Pitavastatin in Japanese Patients With Stable Coronary Artery Disease (REAL-CAD): A Randomized Superiority Trial. Circulation. 2018 May 8;137(19):1997-2009. doi: 10.1161/CIRCULATIONAHA.117.032615.

Responsible Party:	Katsumi Miyauchi, Juntendo University School of Medicine
ClinicalTrials.gov Identifier:	NCT01042730 History of Changes
Other Study ID Numbers:	CSP-LD-09
First Posted:	January 6, 2010
Last Update Posted:	October 18, 2011
Last Verified:	October 2011

Keywords provided by Katsumi Miyauchi, Juntendo University School of Medicine:

Pitavastatin; Coronary Artery Disease; Cardiovascular Disease

Additional relevant MeSH terms:

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