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Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments (POSITIVE)

Primary Purpose

Hypercholesterolemia, Type 2 Diabetes, Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Pravastatin
Rosuvastatin
Sponsored by
Positive Trial Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Hypercholesterolemia with concomitant type 2 diabetes and hypertension

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients meeting the following inclusion criteria will be included in the study:

  1. Patients giving voluntary written consent to participate in the study
  2. Male or female patients 50 years of age or older (at informed consent)
  3. Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)
  4. Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)
  5. Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)

  6. Patients with two or more of the following risk factors

    • Male
    • 65 years of age or older
    • Smoker
    • L/H ratio: ≥3.0 •HbA1c level: ≥8.0%
    • Left ventricular hypertrophy
    • First- or second-degree family history of MACE
    • Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (<60 mL/min/1.73 m2)

Exclusion Criteria:

Patients meeting the following criteria will be excluded from the study:

  1. Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
  2. Patients judged to have familial hypercholesterolemia
  3. Patients with a serum triglyceride level of ≥400 mg/dL
  4. Patients with a history of myocardial infarction
  5. Patients with a history of coronary revascularization (PCI or CABG)
  6. Patients with a history of treatment of unstable angina
  7. Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
  8. Heart failure patients
  9. Patients with a history of hypersensitivity to statins
  10. Patients with a history of drug-induced myopathy
  11. Patients with poorly controlled arrhythmia
  12. Patients with severe liver or kidney disease
  13. Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
  14. Patients who are or may be pregnant
  15. Patients judged by the investigators to be ineligible for participation in the study for any other reason

Sites / Locations

  • Hiramitsu Heart Clinic
  • Medical Dock&Clinic
  • Matsuno Medical Clinic
  • Ishite Matsumoto Naika Junkanki Clinic
  • Ehime Medical CO-OP Izumigawa Clinic
  • Tsugawa Internal Medicine Clinic
  • Fukui Chuo Clinic
  • Koshino Clinic
  • Fukuoka University Chikushi Hospital
  • Saiseikai Futsukaichi Hospital
  • Abies Clinic
  • Hirano Medical Clinic
  • Naitoh Clinic
  • Saku Hospital
  • Fukuoka Tokushukai Medical Center
  • Morizono Naika
  • Kawai Naika Clinic
  • Hiroshima General Hospital of West Japan Railway Company
  • Hijirigaoka Hospital
  • Kyoaikai Hospital
  • Miyazawa Cardiovascular And Internal Medicine Clinic
  • Jiyugaoka Yamada Clinic
  • Chikama Clinic
  • Hiro Clinic
  • Medical and Radiology Clinic Caress Sapporo Hokko Memorial Hospital
  • Seiwa Memorial Hospital
  • Medical Treatment Corporate Foundation Yubari Kibounomori Yubari City Clinic
  • Ino Hospital
  • Katsuya Clinic
  • Kotani Diabetes Clinic
  • Shimizu Clinic
  • Dr. Kodama's Office of Internal Medicine
  • Koga Hospital
  • Imura Internal Medicine Clinic
  • Yanagi Medical Clinic
  • Okyozuka Clinic
  • Koni Clinic
  • Murata Clinic
  • Arai Naika Clinic
  • Dr. Hayakawa's Family Clinic
  • Wakasa Medical Clinic
  • Morita Hospital
  • Kawasaki Family Clinic
  • Sugie Clinic
  • Katsura General Clinic
  • Takamiya General Clinic
  • Hayashi Clinic
  • Otsuka Internal Medicine Clinic
  • Center for Preventive Medical Treatment, NTT West Takamatsu Hospital
  • Hananomiya Clinic
  • Hasegawa Outpatients Clinic for Cardiovascular Disease
  • Kojima Clinic
  • Matsuoka Clinic
  • Osumi-Kanoya Hospital
  • Yakushima Tokushukai Hospital
  • Nemoto G.I.M. Clinic
  • Magokoro Internal Medicine and Orthopedic Clinic
  • Kasuya Clinic
  • Kuboshima Clinic
  • Takahashi Clinic
  • Akizawa Clinic
  • Medical Corp Takeda Clinic
  • Hashimoto Clinic
  • Iroden Clinic
  • Kamakura Naika Shinryosyo
  • Shohei Clinic
  • Hatori Medical Clinic
  • Hirayasu Iin
  • Kamegaya Medical Clinic
  • Kirimura Iin
  • Kojima Clinic
  • Hakuai Iin
  • Sato Clinic
  • Toshiba Rinkan Hospital
  • Yamamoto Clinic
  • Fukumura Clinic
  • Fukushi Clinic
  • International Goodwill Hospital
  • Kikuchi Clinic
  • Matsuo Naika Clinic
  • Miho-cho Cardiovascular Medical Clinic
  • Minamisawa Clinic
  • Miyoshi-Clinic
  • Paula's Clinic
  • Shimokurata Heart Clinic
  • Shinwakai Fukuda Iin
  • Shinyoshida Clinic
  • Suzuki Orthopedic Clinic
  • Yokohama City University Medical Center
  • Yokohama Sotetsu bldg. clinic of internal medicine
  • Hara Clinic
  • Ueta Medical Clinic
  • Nakayama Cardiovascular Clinic
  • Yamashita Clinic
  • National Health Insurance Central Hospital Aso
  • Sakanashi Heart Clinic
  • Koyasako iin
  • Kawaguchi Hospital
  • Miyamoto Internal Clinic
  • Doi Cardiovascular Clinic
  • Doi Naika-ichoka Clinic
  • Haraguchi Circular&Internal Medical Clinic
  • Jinnouchi Clinic Diabetes Care Center
  • Kiyota Junkanki Naika Iin
  • Maki Cardiovascular Clinic
  • Nozuhara Clinic
  • Ootsuka Hospital
  • Shono Heart Clinic
  • Suefuji Naika Junkankika
  • Suizenji Tohya Hospital
  • Terao Hospital
  • Yi Medical Clinic
  • Munakata Clinic
  • Higashi Diabetes and Cardiovascular Clinic
  • Yoshimura Jyunnkannkika Naika Iinn
  • Universal Shipbuilding Co. Ariake Shipyard Ariake Infirmary
  • Miyagi Clinic Cardiovascular Medicine
  • Koide Iin
  • Sawai medical Clinic
  • Asamoto Clinic of Internal Medicine
  • Gotoh Clinic
  • Higashiyama Takeda Hospital
  • Isoda Internal Medical Clinic
  • Omoto Clinic
  • Sakazaki Clinic
  • Shinya Clinic
  • Takagi Cardiology Clinic
  • Takenaka Clinic
  • Tegoshi Clinic
  • Kimura Naika Clinic
  • Shimizu Clinic
  • Horii Clinic Kiodai
  • Yamoto-naika Clinic
  • Seisuikai Yoshioka QQ Clinic
  • Ohtomo Clinic
  • Shimoina Kosei Hospital
  • Yokoyama Medical Clinic
  • Sato Clinic
  • Hoshiko Clinic
  • Shinagawa Clinic
  • Iryohojin Yamamoto Naika
  • Yamada Clinic
  • Uyama Naika Clinic
  • Clinic Jinguumae
  • Kasahara Clinic
  • Sawada Clinic
  • Doi Clinic
  • Medical Corporation Kiriyama Clinic
  • Miyamoto Clinic
  • Oosumi Naika Iin
  • Kondo Clinic Mamigaoka Purified Center
  • Matsuoka Clinic
  • Nakahori Iin
  • Seiwadai Clinic
  • Saiseikai Nara Hospital
  • Takanohara Central Hospital
  • Takanohara Suzuran-naika
  • Ote Clinic of Internal Medicine
  • Sakaguchi Clinic
  • Kokuho Central Hospital
  • Makiura Naika
  • Matsuta Heart Clinic
  • Nakatani Clinic
  • Sano Clinic
  • Kawaguchi Clinic
  • Maeda Medical Clinic
  • Watanabe NJ Clinic
  • Hirata Clinic
  • Ninomiya Clinic
  • Sumi Cardiology Clinic
  • Tokumaru Digestive Internal Medicine Clinic
  • Tsuzaki Clinic
  • Ishida Medical Clinic
  • Hachiouji Naika Clinic
  • Inada Clinic
  • Hisamatsu Medical Clinic
  • Yuhara Naika Clinic
  • Hattori Clinic
  • Nishimura Clinic
  • Ikeda Clinic
  • Ogawa Clinic
  • Taisei Clinic
  • Ishiga Clinic
  • Masuda Clinic
  • Kanazawa Clinic
  • Misugi Clinic
  • Yoshida Clinic
  • Mori Iin
  • Medical Corporation Joukokai Teranishi-geka naika
  • Iryouhoujin Suisyoukai Murata Hospital
  • Izuoka Clinic
  • Keiju Hospital
  • Kondo Clinic
  • Kubota Clinic
  • Matsushita Medical Clinic
  • Nishizawa Clinic
  • Osaka General Medical Center
  • Senpuku Clinic
  • Tai Internal Medicin Clinic
  • Ueda Clinic
  • Ohta Iin
  • Ban Clinic
  • Iryohojin Nogi Naika Iin
  • Kobayashi Clinic
  • Ichida Internal Clinic
  • Yada Clinic
  • Ryo Clinic
  • Matsuo Clinic
  • Enomoto Clinic
  • Medimo Hanyu Clinic
  • Hirose Hospital
  • Iryohojin Hogi Shinryojo
  • Tokutake Iin
  • Gamo Tenjinbashi Clinic
  • Matsumoto Clinic
  • Medical Corporation Shibuya Clinic
  • Akimoto Clinic
  • Iwatsuki-minami Hospital
  • Suzuhiro Clinic
  • Nashida naika clinic
  • Shizuoka Medical Alliance Shirahama Chuou Clinic
  • Akiyama Clinic
  • Aoshima Clinic
  • Eguchi Clinic
  • Shizuoka Hospital
  • Ueno Clinic
  • Takahashi Medical Clinic
  • Iryouhoujin Yuukoukai Morioka Naika Shonika
  • Takada Clinic
  • Masuda Naika
  • Murakami Clinic
  • Fukushima Clinic
  • Yamamoto Naika Ityoka
  • Yuki National Health Insurance Hospital Of Minami Town
  • Sekishinkan Hospital
  • Ueta Clinic
  • Kensei Uchimachi Clinic
  • Kitagawa Naika Ityoka
  • Kitasako Clinic
  • Limbs Tokushima Clinic
  • Matsumura Internal, Gastrointestial Medicine
  • Okagawa Clinic
  • Yokoi Internal Medicine
  • Kimura Internal Medicine Clinic
  • Yata Clinic
  • Okubo Clinic
  • Juntendo University Hospital
  • Choei Clinic
  • Shiraishi Iin
  • Hattori Clinic
  • Toyoizumi Hospital
  • Utsugidai Tajima Clinic
  • Mochizuki Naika Clinic
  • Nishio Clinic
  • Ono Heart Clinic
  • Shiba Palace Clinic
  • Kamada Clinic
  • Tenjinmae Clinic
  • Takayama Iin
  • Sugawara Clinic
  • Yamada Clinic
  • Matsumura Gastroenterological Clinic
  • Magari Clinic
  • Yotsuya Internal Medicine Clinic
  • Yotsuya-Murakami Internal Medicine Clinic
  • Obayashi Clinic
  • Sumidagawa Clinic
  • ISHII Medical Clinic
  • Takahashi Ko Minako Clinic
  • Obanazawa City Clinic
  • Okuyama Clinic
  • Sakae Clinic
  • Honma Clinic
  • Isoda Clinic
  • Nihei Clinic
  • Shimasaki Clinic
  • Yamagata Tokushukai Hospital
  • Iwasaki Naika Iin
  • Kuwahara Clinic
  • Ayame Medical Clinic
  • Johno Clinic
  • Matsuda Medical Clinic
  • Mizumachi Medical Clinic
  • Noda Clinic
  • Fujii Clinic
  • Shakaiiryouhoujin Onaka Hospital
  • Watada-naika Hospital
  • Ouchi Clinic
  • Yoshizaki Clinic
  • Takahashi Clinic
  • Higashikatsura Medical Clinic
  • Fukushi Clinic
  • Kashiwagi Clinic
  • Hayashi Diabetes Clinic
  • Uchiyama Clinic
  • Nitta Medical Clinic
  • Imai Clinic
  • Tani Clinic
  • Marumo Clinic
  • Ihara Clinic
  • Goko-Hospital
  • Satou Clinic
  • Iino Clinic
  • Miura Clinic
  • Kuroda Iin
  • Sasaki Clinic
  • Kamata Clinic of Internal Medicine
  • Nishikawa Clinic
  • Satou Iin
  • Kumagai Clinic
  • Suzuki Clinic
  • Benibana Clinic
  • Fujimi Clinic
  • Hongo Clinic
  • Jiyukai Yamada Naika
  • Shonan Ochanomizu Clinic
  • Tani Clinic Internal Medicine, Allergology & Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Active comparator: Standard Pravastatin Group

Intensive Rosuvastatin Group

Arm Description

Outcomes

Primary Outcome Measures

MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event

Secondary Outcome Measures

Prevention of individual MACE
Prevention of MACE(combination of each category)
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Frequency and distribution of type of deaths during the study period
Frequency and distribution of type of hospitalizations during the study period
Frequency of other events (malignancy, dementia, need of nursing care)
Frequency and type of adverse events
Prevention of individual MACE
Prevention of individual MACE
Prevention of individual MACE
Prevention of individual MACE
Prevention of individual MACE
Prevention of individual MACE
Prevention of MACE(combination of each category)
Prevention of MACE(combination of each category)
Prevention of MACE(combination of each category)
Prevention of MACE(combination of each category)
Prevention of MACE(combination of each category)
Prevention of MACE(combination of each category)
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Frequency and distribution of type of deaths during the study period
Frequency and distribution of type of deaths during the study period
Frequency and distribution of type of deaths during the study period
Frequency and distribution of type of deaths during the study period
Frequency and distribution of type of deaths during the study period
Frequency and distribution of type of deaths during the study period
Frequency and distribution of type of hospitalizations during the study period
Frequency and distribution of type of hospitalizations during the study period
Frequency and distribution of type of hospitalizations during the study period
Frequency and distribution of type of hospitalizations during the study period
Frequency and distribution of type of hospitalizations during the study period
Frequency and distribution of type of hospitalizations during the study period
Frequency of other events (malignancy, dementia, need of nursing care)
Frequency of other events (malignancy, dementia, need of nursing care)
Frequency of other events (malignancy, dementia, need of nursing care)
Frequency of other events (malignancy, dementia, need of nursing care)
Frequency of other events (malignancy, dementia, need of nursing care)
Frequency of other events (malignancy, dementia, need of nursing care)
Frequency and type of adverse events
Frequency and type of adverse events
Frequency and type of adverse events
Frequency and type of adverse events
Frequency and type of adverse events
Frequency and type of adverse events

Full Information

First Posted
July 27, 2010
Last Updated
May 30, 2011
Sponsor
Positive Trial Group
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1. Study Identification

Unique Protocol Identification Number
NCT01173939
Brief Title
Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments
Acronym
POSITIVE
Official Title
Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
With recommendation from IDMC, Steering Committee terminated this trial due to ethical concerns raised by J-ART study.
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Positive Trial Group

4. Oversight

5. Study Description

Brief Summary
The study is being conducted to compare the effect of standard treatment (target LDL-C level: <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: <70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Type 2 Diabetes, Hypertension
Keywords
Hypercholesterolemia with concomitant type 2 diabetes and hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active comparator: Standard Pravastatin Group
Arm Type
Active Comparator
Arm Title
Intensive Rosuvastatin Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Intervention Description
5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)
Primary Outcome Measure Information:
Title
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
Time Frame
At baseline
Title
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
Time Frame
1 month after treatment initiation
Title
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
Time Frame
3 month after treatment initiation
Title
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
Time Frame
6 month after treatment initiation
Title
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
Time Frame
12 month after treatment initiation
Title
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
Time Frame
36 month after treatment initiation
Title
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
Time Frame
At the end of the study or discontinuation up to 4 years
Secondary Outcome Measure Information:
Title
Prevention of individual MACE
Time Frame
At baseline
Title
Prevention of MACE(combination of each category)
Time Frame
At baseline
Title
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Time Frame
At baseline
Title
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Time Frame
At baseline
Title
Frequency and distribution of type of deaths during the study period
Time Frame
At baseline
Title
Frequency and distribution of type of hospitalizations during the study period
Time Frame
At baseline
Title
Frequency of other events (malignancy, dementia, need of nursing care)
Time Frame
At baseline
Title
Frequency and type of adverse events
Time Frame
At baseline
Title
Prevention of individual MACE
Time Frame
1 month after treatment initiation
Title
Prevention of individual MACE
Time Frame
3 month after treatment initiation
Title
Prevention of individual MACE
Time Frame
6 month after treatment initiation
Title
Prevention of individual MACE
Time Frame
12 month after treatment initiation
Title
Prevention of individual MACE
Time Frame
36 month after treatment initiation
Title
Prevention of individual MACE
Time Frame
At the end of the study (or discontinuation)
Title
Prevention of MACE(combination of each category)
Time Frame
1 month after treatment initiation
Title
Prevention of MACE(combination of each category)
Time Frame
3 month after treatment initiation
Title
Prevention of MACE(combination of each category)
Time Frame
6 month after treatment initiation
Title
Prevention of MACE(combination of each category)
Time Frame
12 month after treatment initiation
Title
Prevention of MACE(combination of each category)
Time Frame
36 month after treatment initiation
Title
Prevention of MACE(combination of each category)
Time Frame
At the end of the study (or discontinuation)
Title
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Time Frame
1 month after treatment initiation
Title
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Time Frame
3 month after treatment initiation
Title
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Time Frame
6 month after treatment initiation
Title
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Time Frame
12 month after treatment initiation
Title
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Time Frame
36 month after treatment initiation
Title
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
Time Frame
At study completion up to 4 years
Title
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Time Frame
1 month after treatment initiation
Title
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Time Frame
3 month after treatment initiation
Title
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Time Frame
6 month after treatment initiation
Title
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Time Frame
12 month after treatment initiation
Title
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Time Frame
36 month after treatment initiation
Title
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
Time Frame
At the end of the study or discontinuation up to 4 years
Title
Frequency and distribution of type of deaths during the study period
Time Frame
1 month after treatment initiation
Title
Frequency and distribution of type of deaths during the study period
Time Frame
3 month after treatment initiation
Title
Frequency and distribution of type of deaths during the study period
Time Frame
6 month after treatment initiation
Title
Frequency and distribution of type of deaths during the study period
Time Frame
12 month after treatment initiation
Title
Frequency and distribution of type of deaths during the study period
Time Frame
36 month after treatment initiation
Title
Frequency and distribution of type of deaths during the study period
Time Frame
At the end of the study or discontinuation up to 4 years
Title
Frequency and distribution of type of hospitalizations during the study period
Time Frame
1 month after treatment initiation
Title
Frequency and distribution of type of hospitalizations during the study period
Time Frame
3 month after treatment initiation
Title
Frequency and distribution of type of hospitalizations during the study period
Time Frame
6 month after treatment initiation
Title
Frequency and distribution of type of hospitalizations during the study period
Time Frame
12 month after treatment initiation
Title
Frequency and distribution of type of hospitalizations during the study period
Time Frame
36 month after treatment initiation
Title
Frequency and distribution of type of hospitalizations during the study period
Time Frame
At the end of the study or discontinuation up to 4 years
Title
Frequency of other events (malignancy, dementia, need of nursing care)
Time Frame
1 month after treatment initiation
Title
Frequency of other events (malignancy, dementia, need of nursing care)
Time Frame
3 month after treatment initiation
Title
Frequency of other events (malignancy, dementia, need of nursing care)
Time Frame
6 month after treatment initiation
Title
Frequency of other events (malignancy, dementia, need of nursing care)
Time Frame
12 month after treatment initiation
Title
Frequency of other events (malignancy, dementia, need of nursing care)
Time Frame
36 month after treatment initiation
Title
Frequency of other events (malignancy, dementia, need of nursing care)
Time Frame
At the end of the study or discontinuation up to 4 years
Title
Frequency and type of adverse events
Time Frame
1 month after treatment initiation
Title
Frequency and type of adverse events
Time Frame
3 month after treatment initiation
Title
Frequency and type of adverse events
Time Frame
6 month after treatment initiation
Title
Frequency and type of adverse events
Time Frame
12 month after treatment initiation
Title
Frequency and type of adverse events
Time Frame
36 month after treatment initiation
Title
Frequency and type of adverse events
Time Frame
At the end of the study or discontinuation up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients meeting the following inclusion criteria will be included in the study: Patients giving voluntary written consent to participate in the study Male or female patients 50 years of age or older (at informed consent) Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL) Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy) Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy) Patients with two or more of the following risk factors Male 65 years of age or older Smoker L/H ratio: ≥3.0 •HbA1c level: ≥8.0% Left ventricular hypertrophy First- or second-degree family history of MACE Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (<60 mL/min/1.73 m2) Exclusion Criteria: Patients meeting the following criteria will be excluded from the study: Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent Patients judged to have familial hypercholesterolemia Patients with a serum triglyceride level of ≥400 mg/dL Patients with a history of myocardial infarction Patients with a history of coronary revascularization (PCI or CABG) Patients with a history of treatment of unstable angina Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction) Heart failure patients Patients with a history of hypersensitivity to statins Patients with a history of drug-induced myopathy Patients with poorly controlled arrhythmia Patients with severe liver or kidney disease Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan Patients who are or may be pregnant Patients judged by the investigators to be ineligible for participation in the study for any other reason
Facility Information:
Facility Name
Hiramitsu Heart Clinic
City
Nagoya city
State/Province
Aichi pref.
Country
Japan
Facility Name
Medical Dock&Clinic
City
Nagoya city
State/Province
Aichi pref.
Country
Japan
Facility Name
Matsuno Medical Clinic
City
Iyo gun
State/Province
Ehime pref.
Country
Japan
Facility Name
Ishite Matsumoto Naika Junkanki Clinic
City
Matsuyama city
State/Province
Ehime pref.
Country
Japan
Facility Name
Ehime Medical CO-OP Izumigawa Clinic
City
Niihama city
State/Province
Ehime pref.
Country
Japan
Facility Name
Tsugawa Internal Medicine Clinic
City
Echizen city
State/Province
Fukui pref.
Country
Japan
Facility Name
Fukui Chuo Clinic
City
Fukui city
State/Province
Fukui pref.
Country
Japan
Facility Name
Koshino Clinic
City
Sakai city
State/Province
Fukui pref.
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino city
State/Province
Fukuoka pref.
Country
Japan
Facility Name
Saiseikai Futsukaichi Hospital
City
Chikushino city
State/Province
Fukuoka pref.
Country
Japan
Facility Name
Abies Clinic
City
Fukuoka city
State/Province
Fukuoka pref.
Country
Japan
Facility Name
Hirano Medical Clinic
City
Fukuoka city
State/Province
Fukuoka pref.
Country
Japan
Facility Name
Naitoh Clinic
City
Fukuoka city
State/Province
Fukuoka pref.
Country
Japan
Facility Name
Saku Hospital
City
Fukuoka city
State/Province
Fukuoka pref.
Country
Japan
Facility Name
Fukuoka Tokushukai Medical Center
City
Kasuga city
State/Province
Fukuoka pref.
Country
Japan
Facility Name
Morizono Naika
City
Kitakyusyu city
State/Province
Fukuoka pref.
Country
Japan
Facility Name
Kawai Naika Clinic
City
Gifu city
State/Province
Gifu pref.
Country
Japan
Facility Name
Hiroshima General Hospital of West Japan Railway Company
City
Hiroshima city
State/Province
Hiroshima pref.
Country
Japan
Facility Name
Hijirigaoka Hospital
City
Date city
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Kyoaikai Hospital
City
Hakodate city
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Miyazawa Cardiovascular And Internal Medicine Clinic
City
Kato-gun
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Jiyugaoka Yamada Clinic
City
Obihiro city
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Chikama Clinic
City
Sapporo city
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Hiro Clinic
City
Sapporo city
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Medical and Radiology Clinic Caress Sapporo Hokko Memorial Hospital
City
Sapporo city
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Seiwa Memorial Hospital
City
Sapporo city
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Medical Treatment Corporate Foundation Yubari Kibounomori Yubari City Clinic
City
Yubari city
State/Province
Hokkaido pref.
Country
Japan
Facility Name
Ino Hospital
City
Himeji city
State/Province
Hyogo pref.
Country
Japan
Facility Name
Katsuya Clinic
City
Amagasaki city
State/Province
Hyogo pref
Country
Japan
Facility Name
Kotani Diabetes Clinic
City
Kobe city
State/Province
Hyogo pref
Country
Japan
Facility Name
Shimizu Clinic
City
Kobe city
State/Province
Hyogo pref
Country
Japan
Facility Name
Dr. Kodama's Office of Internal Medicine
City
Nishinomiya city
State/Province
Hyogo pref
Country
Japan
Facility Name
Koga Hospital
City
Koga city
State/Province
Ibaraki pref.
Country
Japan
Facility Name
Imura Internal Medicine Clinic
City
Hakusan city
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Yanagi Medical Clinic
City
Hakusan city
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Okyozuka Clinic
City
Ishikawa gun
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Koni Clinic
City
Kahoku gun
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Murata Clinic
City
Kahoku gun
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Arai Naika Clinic
City
Kanazawa city
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Dr. Hayakawa's Family Clinic
City
Kanazawa city
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Wakasa Medical Clinic
City
Kanazawa city
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Morita Hospital
City
Komatsu city
State/Province
Ishikawa pref.
Country
Japan
Facility Name
Kawasaki Family Clinic
City
Ichinoseki
State/Province
Iwate pref.
Country
Japan
Facility Name
Sugie Clinic
City
Iwate gun
State/Province
Iwate pref.
Country
Japan
Facility Name
Katsura General Clinic
City
Morioka city
State/Province
Iwate pref.
Country
Japan
Facility Name
Takamiya General Clinic
City
Shiwa gun
State/Province
Iwate pref.
Country
Japan
Facility Name
Hayashi Clinic
City
Marugame city
State/Province
Kagawa pref.
Country
Japan
Facility Name
Otsuka Internal Medicine Clinic
City
Marugame city
State/Province
Kagawa pref.
Country
Japan
Facility Name
Center for Preventive Medical Treatment, NTT West Takamatsu Hospital
City
Takamatsu city
State/Province
Kagawa pref.
Country
Japan
Facility Name
Hananomiya Clinic
City
Takamatsu city
State/Province
Kagawa pref.
Country
Japan
Facility Name
Hasegawa Outpatients Clinic for Cardiovascular Disease
City
Takamatsu city
State/Province
Kagawa pref.
Country
Japan
Facility Name
Kojima Clinic
City
Takamatsu city
State/Province
Kagawa pref.
Country
Japan
Facility Name
Matsuoka Clinic
City
Takamatsu city
State/Province
Kagawa pref.
Country
Japan
Facility Name
Osumi-Kanoya Hospital
City
Kanoya city
State/Province
Kagoshima pref.
Country
Japan
Facility Name
Yakushima Tokushukai Hospital
City
Kumage gun
State/Province
Kagoshima pref.
Country
Japan
Facility Name
Nemoto G.I.M. Clinic
City
Ashigara-kami gun
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Magokoro Internal Medicine and Orthopedic Clinic
City
Ashigarakami gun
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Kasuya Clinic
City
Atsugi City
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Kuboshima Clinic
City
Fujisawa city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Takahashi Clinic
City
Fujisawa city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Akizawa Clinic
City
Isehara city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Medical Corp Takeda Clinic
City
Isehara city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Hashimoto Clinic
City
Kamakura city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Iroden Clinic
City
Kamakura city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Kamakura Naika Shinryosyo
City
Kamakura city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Shohei Clinic
City
Kamakura city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Hatori Medical Clinic
City
Kawasaki city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Hirayasu Iin
City
Kawasaki city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Kamegaya Medical Clinic
City
Kawasaki city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Kirimura Iin
City
Kawasaki city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Kojima Clinic
City
Odawara city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Hakuai Iin
City
Sagamihara city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Sato Clinic
City
Sagamihara city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Toshiba Rinkan Hospital
City
Sagamihara city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Yamamoto Clinic
City
Sagamihara city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Fukumura Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Fukushi Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
International Goodwill Hospital
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Kikuchi Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Matsuo Naika Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Miho-cho Cardiovascular Medical Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Minamisawa Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Miyoshi-Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Paula's Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Shimokurata Heart Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Shinwakai Fukuda Iin
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Shinyoshida Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Suzuki Orthopedic Clinic
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Yokohama Sotetsu bldg. clinic of internal medicine
City
Yokohama city
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Hara Clinic
City
Yokosuka City
State/Province
Kanagawa pref.
Country
Japan
Facility Name
Ueta Medical Clinic
City
Kochi city
State/Province
Kochi pref.
Country
Japan
Facility Name
Nakayama Cardiovascular Clinic
City
Amakusa city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Yamashita Clinic
City
Amakusa city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
National Health Insurance Central Hospital Aso
City
Aso city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Sakanashi Heart Clinic
City
Aso city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Koyasako iin
City
Kamimashiki gun
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Kawaguchi Hospital
City
Kikuchi city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Miyamoto Internal Clinic
City
Kikuchi city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Doi Cardiovascular Clinic
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Doi Naika-ichoka Clinic
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Haraguchi Circular&Internal Medical Clinic
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Jinnouchi Clinic Diabetes Care Center
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Kiyota Junkanki Naika Iin
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Maki Cardiovascular Clinic
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Nozuhara Clinic
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Ootsuka Hospital
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Shono Heart Clinic
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Suefuji Naika Junkankika
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Suizenji Tohya Hospital
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Terao Hospital
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Yi Medical Clinic
City
Kumamoto city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Munakata Clinic
City
Shimomashiki gun
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Higashi Diabetes and Cardiovascular Clinic
City
Tamana city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Yoshimura Jyunnkannkika Naika Iinn
City
Tamana city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Universal Shipbuilding Co. Ariake Shipyard Ariake Infirmary
City
Tamana gun
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Miyagi Clinic Cardiovascular Medicine
City
Yatsushiro city
State/Province
Kumamoto pref.
Country
Japan
Facility Name
Koide Iin
City
Kizugawa-city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Sawai medical Clinic
City
Kyotanabe city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Asamoto Clinic of Internal Medicine
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Gotoh Clinic
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Higashiyama Takeda Hospital
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Isoda Internal Medical Clinic
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Omoto Clinic
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Sakazaki Clinic
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Shinya Clinic
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Takagi Cardiology Clinic
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Takenaka Clinic
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Tegoshi Clinic
City
Kyoto city
State/Province
Kyoto pref.
Country
Japan
Facility Name
Kimura Naika Clinic
City
Yosa gun
State/Province
Kyoto pref.
Country
Japan
Facility Name
Shimizu Clinic
City
Ise city
State/Province
Mie pref.
Country
Japan
Facility Name
Horii Clinic Kiodai
City
Nabari city
State/Province
Mie pref.
Country
Japan
Facility Name
Yamoto-naika Clinic
City
Higashi matsushima city
State/Province
Miyagi pref.
Country
Japan
Facility Name
Seisuikai Yoshioka QQ Clinic
City
Kurokawa gun
State/Province
Miyagi pref.
Country
Japan
Facility Name
Ohtomo Clinic
City
Tome City
State/Province
Miyagi pref.
Country
Japan
Facility Name
Shimoina Kosei Hospital
City
Shimoina gun
State/Province
Nagano pref.
Country
Japan
Facility Name
Yokoyama Medical Clinic
City
Shiojiri city
State/Province
Nagano pref.
Country
Japan
Facility Name
Sato Clinic
City
Suzaka city
State/Province
Nagano pref.
Country
Japan
Facility Name
Hoshiko Clinic
City
Nagasaki city
State/Province
Nagasaki pref.
Country
Japan
Facility Name
Shinagawa Clinic
City
Nagasaki city
State/Province
Nagasaki pref.
Country
Japan
Facility Name
Iryohojin Yamamoto Naika
City
Nishisonogi gun
State/Province
Nagasaki pref.
Country
Japan
Facility Name
Yamada Clinic
City
Gojo city
State/Province
Nara pref.
Country
Japan
Facility Name
Uyama Naika Clinic
City
Ikoma city
State/Province
Nara pref.
Country
Japan
Facility Name
Clinic Jinguumae
City
Kahihara city
State/Province
Nara pref.
Country
Japan
Facility Name
Kasahara Clinic
City
Kahihara city
State/Province
Nara pref.
Country
Japan
Facility Name
Sawada Clinic
City
Kashiba city
State/Province
Nara pref.
Country
Japan
Facility Name
Doi Clinic
City
Kashihara city
State/Province
Nara pref.
Country
Japan
Facility Name
Medical Corporation Kiriyama Clinic
City
Kashihara city
State/Province
Nara pref.
Country
Japan
Facility Name
Miyamoto Clinic
City
Kashihara city
State/Province
Nara pref.
Country
Japan
Facility Name
Oosumi Naika Iin
City
Kashihara city
State/Province
Nara pref.
Country
Japan
Facility Name
Kondo Clinic Mamigaoka Purified Center
City
Kitakatsuragi gun
State/Province
Nara pref.
Country
Japan
Facility Name
Matsuoka Clinic
City
Kitakatsuragi gun
State/Province
Nara pref.
Country
Japan
Facility Name
Nakahori Iin
City
Kitakatsuragi gun
State/Province
Nara pref.
Country
Japan
Facility Name
Seiwadai Clinic
City
Kitakatsuragi gun
State/Province
Nara pref.
Country
Japan
Facility Name
Saiseikai Nara Hospital
City
Nara city
State/Province
Nara pref.
Country
Japan
Facility Name
Takanohara Central Hospital
City
Nara city
State/Province
Nara pref.
Country
Japan
Facility Name
Takanohara Suzuran-naika
City
Nara city
State/Province
Nara pref.
Country
Japan
Facility Name
Ote Clinic of Internal Medicine
City
Sakurai city
State/Province
Nara pref.
Country
Japan
Facility Name
Sakaguchi Clinic
City
Sakurai city
State/Province
Nara pref.
Country
Japan
Facility Name
Kokuho Central Hospital
City
Shiki gun
State/Province
Nara pref.
Country
Japan
Facility Name
Makiura Naika
City
Yamatokoriyama city
State/Province
Nara pref.
Country
Japan
Facility Name
Matsuta Heart Clinic
City
Yamatokoriyama city
State/Province
Nara pref.
Country
Japan
Facility Name
Nakatani Clinic
City
Yamatotakada city
State/Province
Nara pref.
Country
Japan
Facility Name
Sano Clinic
City
Murakami city
State/Province
Niigata pref.
Country
Japan
Facility Name
Kawaguchi Clinic
City
Nagaoka city
State/Province
Niigata pref.
Country
Japan
Facility Name
Maeda Medical Clinic
City
Niigata city
State/Province
Niigata pref.
Country
Japan
Facility Name
Watanabe NJ Clinic
City
Beppu city
State/Province
Oiat pref.
Country
Japan
Facility Name
Hirata Clinic
City
Oita city
State/Province
Oiat pref.
Country
Japan
Facility Name
Ninomiya Clinic
City
Oita city
State/Province
Oiat pref.
Country
Japan
Facility Name
Sumi Cardiology Clinic
City
Oita city
State/Province
Oiat pref.
Country
Japan
Facility Name
Tokumaru Digestive Internal Medicine Clinic
City
Oita city
State/Province
Oiat pref.
Country
Japan
Facility Name
Tsuzaki Clinic
City
Oita city
State/Province
Oiat pref.
Country
Japan
Facility Name
Ishida Medical Clinic
City
Usa city
State/Province
Oiat pref.
Country
Japan
Facility Name
Hachiouji Naika Clinic
City
Kurashiki city
State/Province
Okayama pref.
Country
Japan
Facility Name
Inada Clinic
City
Kurashiki city
State/Province
Okayama pref.
Country
Japan
Facility Name
Hisamatsu Medical Clinic
City
Okayama city
State/Province
Okayama pref.
Country
Japan
Facility Name
Yuhara Naika Clinic
City
Okayama city
State/Province
Okayama pref.
Country
Japan
Facility Name
Hattori Clinic
City
Setouchi city
State/Province
Okayama pref.
Country
Japan
Facility Name
Nishimura Clinic
City
Fujiidera city
State/Province
Osaka pref.
Country
Japan
Facility Name
Ikeda Clinic
City
Higashiosaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Ogawa Clinic
City
Higashiosaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Taisei Clinic
City
Hirakata city
State/Province
Osaka pref.
Country
Japan
Facility Name
Ishiga Clinic
City
Ibaraki city
State/Province
Osaka pref.
Country
Japan
Facility Name
Masuda Clinic
City
Ibaraki city
State/Province
Osaka pref.
Country
Japan
Facility Name
Kanazawa Clinic
City
Izumi city
State/Province
Osaka pref.
Country
Japan
Facility Name
Misugi Clinic
City
Kaizuka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Yoshida Clinic
City
Kaizuka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Mori Iin
City
Kishiwada city
State/Province
Osaka pref.
Country
Japan
Facility Name
Medical Corporation Joukokai Teranishi-geka naika
City
Moriguchi city
State/Province
Osaka pref.
Country
Japan
Facility Name
Iryouhoujin Suisyoukai Murata Hospital
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Izuoka Clinic
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Keiju Hospital
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Kondo Clinic
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Kubota Clinic
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Matsushita Medical Clinic
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Nishizawa Clinic
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Senpuku Clinic
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Tai Internal Medicin Clinic
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Ueda Clinic
City
Osaka city
State/Province
Osaka pref.
Country
Japan
Facility Name
Ohta Iin
City
Sakai city
State/Province
Osaka pref.
Country
Japan
Facility Name
Ban Clinic
City
Suita city
State/Province
Osaka pref.
Country
Japan
Facility Name
Iryohojin Nogi Naika Iin
City
Suita city
State/Province
Osaka pref.
Country
Japan
Facility Name
Kobayashi Clinic
City
Suita city
State/Province
Osaka pref.
Country
Japan
Facility Name
Ichida Internal Clinic
City
Takaishi city
State/Province
Osaka pref.
Country
Japan
Facility Name
Yada Clinic
City
Takaishi city
State/Province
Osaka pref.
Country
Japan
Facility Name
Ryo Clinic
City
Takatsuki city
State/Province
Osaka pref.
Country
Japan
Facility Name
Matsuo Clinic
City
Yao city
State/Province
Osaka pref.
Country
Japan
Facility Name
Enomoto Clinic
City
Ageo city
State/Province
Saitama pref.
Country
Japan
Facility Name
Medimo Hanyu Clinic
City
Hanyu city
State/Province
Saitama pref.
Country
Japan
Facility Name
Hirose Hospital
City
Kawagoe city
State/Province
Saitama pref.
Country
Japan
Facility Name
Iryohojin Hogi Shinryojo
City
Kawaguchi city
State/Province
Saitama pref.
Country
Japan
Facility Name
Tokutake Iin
City
Kawaguchi city
State/Province
Saitama pref.
Country
Japan
Facility Name
Gamo Tenjinbashi Clinic
City
Koshigaya city
State/Province
Saitama pref.
Country
Japan
Facility Name
Matsumoto Clinic
City
Koshigaya city
State/Province
Saitama pref.
Country
Japan
Facility Name
Medical Corporation Shibuya Clinic
City
Kumagaya city
State/Province
Saitama pref.
Country
Japan
Facility Name
Akimoto Clinic
City
Saitama city
State/Province
Saitama pref.
Country
Japan
Facility Name
Iwatsuki-minami Hospital
City
Saitama city
State/Province
Saitama pref.
Country
Japan
Facility Name
Suzuhiro Clinic
City
Saitama city
State/Province
Saitama pref.
Country
Japan
Facility Name
Nashida naika clinic
City
Tokorozawa City
State/Province
Saitama pref.
Country
Japan
Facility Name
Shizuoka Medical Alliance Shirahama Chuou Clinic
City
Shimoda city
State/Province
Shizuoka pref.
Country
Japan
Facility Name
Akiyama Clinic
City
Shizuoka city
State/Province
Shizuoka pref.
Country
Japan
Facility Name
Aoshima Clinic
City
Shizuoka city
State/Province
Shizuoka pref.
Country
Japan
Facility Name
Eguchi Clinic
City
Shizuoka city
State/Province
Shizuoka pref.
Country
Japan
Facility Name
Shizuoka Hospital
City
Shizuoka city
State/Province
Shizuoka pref.
Country
Japan
Facility Name
Ueno Clinic
City
Yaizu city
State/Province
Shizuoka pref.
Country
Japan
Facility Name
Takahashi Medical Clinic
City
Ohtawara city
State/Province
Tochigi pref.
Country
Japan
Facility Name
Iryouhoujin Yuukoukai Morioka Naika Shonika
City
Oyama city
State/Province
Tochigi pref.
Country
Japan
Facility Name
Takada Clinic
City
Tochigi city
State/Province
Tochigi pref.
Country
Japan
Facility Name
Masuda Naika
City
Utsunomiya city
State/Province
Tochigi pref.
Country
Japan
Facility Name
Murakami Clinic
City
Anan city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Fukushima Clinic
City
Itano gun
State/Province
Tokushima pref.
Country
Japan
Facility Name
Yamamoto Naika Ityoka
City
Itano gun
State/Province
Tokushima pref.
Country
Japan
Facility Name
Yuki National Health Insurance Hospital Of Minami Town
City
Kaifu gun
State/Province
Tokushima pref.
Country
Japan
Facility Name
Sekishinkan Hospital
City
Komatsushima city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Ueta Clinic
City
Myozai gun
State/Province
Tokushima pref.
Country
Japan
Facility Name
Kensei Uchimachi Clinic
City
Tokushima city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Kitagawa Naika Ityoka
City
Tokushima city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Kitasako Clinic
City
Tokushima city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Limbs Tokushima Clinic
City
Tokushima city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Matsumura Internal, Gastrointestial Medicine
City
Tokushima city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Okagawa Clinic
City
Tokushima city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Yokoi Internal Medicine
City
Tokushima city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Kimura Internal Medicine Clinic
City
Yoshinokawa city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Yata Clinic
City
Yoshinokawa city
State/Province
Tokushima pref.
Country
Japan
Facility Name
Okubo Clinic
City
Akishima city
State/Province
Tokyo
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo ku
State/Province
Tokyo
Country
Japan
Facility Name
Choei Clinic
City
Edogawa ku
State/Province
Tokyo
Country
Japan
Facility Name
Shiraishi Iin
City
Edogawa ku
State/Province
Tokyo
Country
Japan
Facility Name
Hattori Clinic
City
Hachioji city
State/Province
Tokyo
Country
Japan
Facility Name
Toyoizumi Hospital
City
Hachioji city
State/Province
Tokyo
Country
Japan
Facility Name
Utsugidai Tajima Clinic
City
Hachioji City
State/Province
Tokyo
Country
Japan
Facility Name
Mochizuki Naika Clinic
City
Itabashi ku
State/Province
Tokyo
Country
Japan
Facility Name
Nishio Clinic
City
Itabashi ku
State/Province
Tokyo
Country
Japan
Facility Name
Ono Heart Clinic
City
Koto ku
State/Province
Tokyo
Country
Japan
Facility Name
Shiba Palace Clinic
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kamada Clinic
City
Mitaka city
State/Province
Tokyo
Country
Japan
Facility Name
Tenjinmae Clinic
City
Mitaka city
State/Province
Tokyo
Country
Japan
Facility Name
Takayama Iin
City
Mitaka-shi
State/Province
Tokyo
Country
Japan
Facility Name
Sugawara Clinic
City
Nerima ku
State/Province
Tokyo
Country
Japan
Facility Name
Yamada Clinic
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Matsumura Gastroenterological Clinic
City
Setagaya ku
State/Province
Tokyo
Country
Japan
Facility Name
Magari Clinic
City
Shinjuku ku
State/Province
Tokyo
Country
Japan
Facility Name
Yotsuya Internal Medicine Clinic
City
Shinjuku ku
State/Province
Tokyo
Country
Japan
Facility Name
Yotsuya-Murakami Internal Medicine Clinic
City
Shinjuku ku
State/Province
Tokyo
Country
Japan
Facility Name
Obayashi Clinic
City
Sumida city
State/Province
Tokyo
Country
Japan
Facility Name
Sumidagawa Clinic
City
Sumida ku
State/Province
Tokyo
Country
Japan
Facility Name
ISHII Medical Clinic
City
Tachikawa-shi
State/Province
Tokyo
Country
Japan
Facility Name
Takahashi Ko Minako Clinic
City
Murayama city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Obanazawa City Clinic
City
Obanazawa city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Okuyama Clinic
City
Obanazawa city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Sakae Clinic
City
Obanazawa city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Honma Clinic
City
Sakata city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Isoda Clinic
City
Yamagata city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Nihei Clinic
City
Yamagata city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Shimasaki Clinic
City
Yamagata city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Yamagata Tokushukai Hospital
City
Yamagata city
State/Province
Yamagata pref.
Country
Japan
Facility Name
Iwasaki Naika Iin
City
Iwakuni city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Kuwahara Clinic
City
Iwakuni city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Ayame Medical Clinic
City
Shimonoseki city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Johno Clinic
City
Shimonoseki city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Matsuda Medical Clinic
City
Shimonoseki city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Mizumachi Medical Clinic
City
Shimonoseki city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Noda Clinic
City
Shimonoseki city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Fujii Clinic
City
Ube City
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Shakaiiryouhoujin Onaka Hospital
City
Ube City
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Watada-naika Hospital
City
Ube city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Ouchi Clinic
City
Yamaguchi city
State/Province
Yamaguchi pref.
Country
Japan
Facility Name
Yoshizaki Clinic
City
Chuo city
State/Province
Yamanashi pref.
Country
Japan
Facility Name
Takahashi Clinic
City
Nishi Yatsushiro gun
State/Province
Yamanashi pref.
Country
Japan
Facility Name
Higashikatsura Medical Clinic
City
Tsuru city
State/Province
Yamanashi pref.
Country
Japan
Facility Name
Fukushi Clinic
City
Aomori city
Country
Japan
Facility Name
Kashiwagi Clinic
City
Ayase city
Country
Japan
Facility Name
Hayashi Diabetes Clinic
City
Chigasaki city
Country
Japan
Facility Name
Uchiyama Clinic
City
Joetsu city
Country
Japan
Facility Name
Nitta Medical Clinic
City
Kamiinagun
Country
Japan
Facility Name
Imai Clinic
City
Kawasaki city
Country
Japan
Facility Name
Tani Clinic
City
Kitakyusyu City
Country
Japan
Facility Name
Marumo Clinic
City
Koganei city
Country
Japan
Facility Name
Ihara Clinic
City
Kyoto city
Country
Japan
Facility Name
Goko-Hospital
City
Matsudo city
Country
Japan
Facility Name
Satou Clinic
City
Moka city
Country
Japan
Facility Name
Iino Clinic
City
Nirasaki city
Country
Japan
Facility Name
Miura Clinic
City
Osaka City
Country
Japan
Facility Name
Kuroda Iin
City
Otsuki City
Country
Japan
Facility Name
Sasaki Clinic
City
Sendai city
Country
Japan
Facility Name
Kamata Clinic of Internal Medicine
City
Shiki city
Country
Japan
Facility Name
Nishikawa Clinic
City
Shimoda city
Country
Japan
Facility Name
Satou Iin
City
Shimoinagun
Country
Japan
Facility Name
Kumagai Clinic
City
Shinshiro city
Country
Japan
Facility Name
Suzuki Clinic
City
Toyokawa city
Country
Japan
Facility Name
Benibana Clinic
City
Yamagata city
Country
Japan
Facility Name
Fujimi Clinic
City
Yokohama city
Country
Japan
Facility Name
Hongo Clinic
City
Yokohama city
Country
Japan
Facility Name
Jiyukai Yamada Naika
City
Yokohama city
Country
Japan
Facility Name
Shonan Ochanomizu Clinic
City
Yokohama city
Country
Japan
Facility Name
Tani Clinic Internal Medicine, Allergology & Rheumatology
City
Yokohama city
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments

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