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| Name | Class |
|---|---|
| Tokyo University | OTHER |
| Yamaguchi University Hospital | OTHER |
| Tohoku University | OTHER |
| Kyoto University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 1 mg daily | Active Comparator |
| |
| Pitavastatin 4 mg daily | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin 1 mg daily or 4 mg daily | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization) | 3-6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Composite cardiovascular events | 3-6 years | |
| Composite coronary heart disease events | 3-6 years | |
| Composite cerebrovascular events |
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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
Hypercholesterolemia patients meeting one of following criteria
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 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)
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| Name | Affiliation | Role |
|---|---|---|
| Ryozo 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Hospital | Kyoto | 606-8507 | Japan | |||
| Juntendo University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39818975 | Derived | Yoshiki Y, Ozaki Y, Abe M, Ismail TF, Takahashi H, Akao M, Kawai H, Muramatsu T, Harada M, Ohta M, Hashimoto Y, Shiki Y, Koshikawa M, Miyajima K, Takatsu H, Niwa Y, Kawashima N, Ozaki R, Tsuboi N, Iimuro S, Iwata H, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Miyauchi K, Ogawa H, Daida H, Shimokawa H, Izawa H, Kimura T, Nagai R; REAL-CAD investigators. Influence of Worsening Renal Function and Baseline Chronic Kidney Disease on Clinical Outcomes in Patients With Chronic Coronary Syndromes: Insights From the REAL-CAD Study. J Am Heart Assoc. 2025 Jan 21;14(2):e034627. doi: 10.1161/JAHA.124.034627. Epub 2025 Jan 17. | |
| 39130048 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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| OTHER |
| Kumamoto University | OTHER |
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|
|
| 3-6 years |
| Death events | 3-6 years |
| Heart disease events | 3-6 years |
| Cerebrovascular events | 3-6 years |
| The other events | 3-6 years |
| Tokyo |
| Japan |
| Derived |
| Iwata H, Miyauchi K, Naito R, Iimuro S, Ozaki Y, Sakuma I, Nakagawa Y, Hibi K, Hiro T, Fukumoto Y, Hokimoto S, Saito Y, Ogawa H, Shimokawa H, Daida H, Kimura T, Nagai R. Significance of Persistent Inflammation in Patients With Chronic Coronary Syndrome: Insights From the REAL-CAD Study. JACC Adv. 2024 Jun 5;3(7):100996. doi: 10.1016/j.jacadv.2024.100996. eCollection 2024 Jul. |
| 36372869 | Derived | Sakuma M, Iimuro S, Shinozaki T, Kimura T, Nakagawa Y, Ozaki Y, Iwata H, Miyauchi K, Daida H, Suwa S, Sakuma I, Nishihata Y, Saito Y, Ogawa H, Matsuzaki M, Ohashi Y, Taguchi I, Toyoda S, Inoue T, Nagai R. Optimal target of LDL cholesterol level for statin treatment: challenges to monotonic relationship with cardiovascular events. BMC Med. 2022 Nov 14;20(1):441. doi: 10.1186/s12916-022-02633-5. |
| 29735587 | Derived | 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. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |