Rationale and design of randomized evaluation of aggressive or moderate lipid lowering therapy with pitavastatin in coronary artery disease (REAL-CAD) trial

REAL-CAD Trial Investigaters

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Large-scale clinical trials in patients in Western countries with coronary artery disease (CAD) have found that aggressive lipid-lowering therapy using high-dose statins reduces cardiovascular (CV) events further than low-dose statins. However such evidence has not yet been fully established in Asian populations including in Japan. The Randomized Evaluation of Aggressive or Moderate Lipid-Lowering Therapy with Pitavastatin in Coronary Artery Disease (REAL-CAD) study addresses whether intensification of statin therapy improves clinical outcomes in Japanese patients with CAD. REAL-CAD is a prospective multicenter randomized open-label blinded-endpoint physician-initiated phase 4 trial in Japan. The study will recruit up to 12,600 patients with stable CAD. Patients are assigned to receive either pitavastatin 1 mg/day or pitavastatin 4 mg/day. LDL-C levels are expected to reach approximate mean values of 100 mg/dL in the low-dose pitavastatin group 80 mg/dL in the high-dose group. The primary endpoint is the time to occurrence of a major CV event including CV death non-fatal myocardial infarction non-fatal ischemic strokeunstable angina requiring emergency hospitalization during an average of 5 years. The large number of patients the long follow-up period in the REAL-CAD study should ensure that there is adequate power to definitively determine if reducing LDL-C levels to approximately 80 mg/dL by high-dose statin can provide additional clinical benefit. After the study is completed we will have categorical evidence on the optimal statin dose target LDL-C level for secondary prevention in Japanese patients.

Original languageEnglish
Pages (from-to)315-320
Number of pages6
JournalInternational heart journal
Volume59
Issue number2
DOIs
Publication statusPublished - 01-01-2018

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Artery Disease
Lipids
Therapeutics
Japan
Secondary Prevention
pitavastatin
Hospitalization
Emergencies
Myocardial Infarction
Clinical Trials
Physicians
Population
oxidized low density lipoprotein

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

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title = "Rationale and design of randomized evaluation of aggressive or moderate lipid lowering therapy with pitavastatin in coronary artery disease (REAL-CAD) trial",
abstract = "Large-scale clinical trials in patients in Western countries with coronary artery disease (CAD) have found that aggressive lipid-lowering therapy using high-dose statins reduces cardiovascular (CV) events further than low-dose statins. However such evidence has not yet been fully established in Asian populations including in Japan. The Randomized Evaluation of Aggressive or Moderate Lipid-Lowering Therapy with Pitavastatin in Coronary Artery Disease (REAL-CAD) study addresses whether intensification of statin therapy improves clinical outcomes in Japanese patients with CAD. REAL-CAD is a prospective multicenter randomized open-label blinded-endpoint physician-initiated phase 4 trial in Japan. The study will recruit up to 12,600 patients with stable CAD. Patients are assigned to receive either pitavastatin 1 mg/day or pitavastatin 4 mg/day. LDL-C levels are expected to reach approximate mean values of 100 mg/dL in the low-dose pitavastatin group 80 mg/dL in the high-dose group. The primary endpoint is the time to occurrence of a major CV event including CV death non-fatal myocardial infarction non-fatal ischemic strokeunstable angina requiring emergency hospitalization during an average of 5 years. The large number of patients the long follow-up period in the REAL-CAD study should ensure that there is adequate power to definitively determine if reducing LDL-C levels to approximately 80 mg/dL by high-dose statin can provide additional clinical benefit. After the study is completed we will have categorical evidence on the optimal statin dose target LDL-C level for secondary prevention in Japanese patients.",
author = "{REAL-CAD Trial Investigaters} and Katsumi Miyauchi and Takeshi Kimura and Hiroaki Shimokawa and Hiroyuki Daida and Satoshi Iimuro and Hiroshi Iwata and Yukio Ozaki and Ichiro Sakuma and Yoshihisa Nakagawa and Kiyoshi Hibi and Takafumi Hiro and Yoshihiro Fukumoto and Seiji Hokimoto and Yasuo Ohashi and Hiroshi Ohtsu and Yasushi Saito and Masunori Matsuzaki and Ryozo Nagai",
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Rationale and design of randomized evaluation of aggressive or moderate lipid lowering therapy with pitavastatin in coronary artery disease (REAL-CAD) trial. / REAL-CAD Trial Investigaters.

In: International heart journal, Vol. 59, No. 2, 01.01.2018, p. 315-320.

Research output: Contribution to journalArticle

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T1 - Rationale and design of randomized evaluation of aggressive or moderate lipid lowering therapy with pitavastatin in coronary artery disease (REAL-CAD) trial

AU - REAL-CAD Trial Investigaters

AU - Miyauchi, Katsumi

AU - Kimura, Takeshi

AU - Shimokawa, Hiroaki

AU - Daida, Hiroyuki

AU - Iimuro, Satoshi

AU - Iwata, Hiroshi

AU - Ozaki, Yukio

AU - Sakuma, Ichiro

AU - Nakagawa, Yoshihisa

AU - Hibi, Kiyoshi

AU - Hiro, Takafumi

AU - Fukumoto, Yoshihiro

AU - Hokimoto, Seiji

AU - Ohashi, Yasuo

AU - Ohtsu, Hiroshi

AU - Saito, Yasushi

AU - Matsuzaki, Masunori

AU - Nagai, Ryozo

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Large-scale clinical trials in patients in Western countries with coronary artery disease (CAD) have found that aggressive lipid-lowering therapy using high-dose statins reduces cardiovascular (CV) events further than low-dose statins. However such evidence has not yet been fully established in Asian populations including in Japan. The Randomized Evaluation of Aggressive or Moderate Lipid-Lowering Therapy with Pitavastatin in Coronary Artery Disease (REAL-CAD) study addresses whether intensification of statin therapy improves clinical outcomes in Japanese patients with CAD. REAL-CAD is a prospective multicenter randomized open-label blinded-endpoint physician-initiated phase 4 trial in Japan. The study will recruit up to 12,600 patients with stable CAD. Patients are assigned to receive either pitavastatin 1 mg/day or pitavastatin 4 mg/day. LDL-C levels are expected to reach approximate mean values of 100 mg/dL in the low-dose pitavastatin group 80 mg/dL in the high-dose group. The primary endpoint is the time to occurrence of a major CV event including CV death non-fatal myocardial infarction non-fatal ischemic strokeunstable angina requiring emergency hospitalization during an average of 5 years. The large number of patients the long follow-up period in the REAL-CAD study should ensure that there is adequate power to definitively determine if reducing LDL-C levels to approximately 80 mg/dL by high-dose statin can provide additional clinical benefit. After the study is completed we will have categorical evidence on the optimal statin dose target LDL-C level for secondary prevention in Japanese patients.

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