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

Hypertension Clinical Trial

— POSITIVE  

Official title:

Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01173939
• Other study ID #: 0035
• Status: Terminated
• Phase: N/A
• First received: July 27, 2010
• Last updated: May 30, 2011
• Start date: July 2010

Study information

• Verified date: November 2010
• Source: Positive Trial Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10000
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Hypertension
• Type 2 Diabetes

Intervention

Drug:
• Pravastatin
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)
• Rosuvastatin
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)

Locations

Country	Name	City	State
Japan	Enomoto Clinic	Ageo city	Saitama pref.
Japan	Okubo Clinic	Akishima city	Tokyo
Japan	Katsuya Clinic	Amagasaki city	Hyogo pref
Japan	Nakayama Cardiovascular Clinic	Amakusa city	Kumamoto pref.
Japan	Yamashita Clinic	Amakusa city	Kumamoto pref.
Japan	Murakami Clinic	Anan city	Tokushima pref.
Japan	Fukushi Clinic	Aomori city
Japan	Nemoto G.I.M. Clinic	Ashigara-kami gun	Kanagawa pref.
Japan	Magokoro Internal Medicine and Orthopedic Clinic	Ashigarakami gun	Kanagawa pref.
Japan	National Health Insurance Central Hospital Aso	Aso city	Kumamoto pref.
Japan	Sakanashi Heart Clinic	Aso city	Kumamoto pref.
Japan	Kasuya Clinic	Atsugi City	Kanagawa pref.
Japan	Kashiwagi Clinic	Ayase city
Japan	Watanabe NJ Clinic	Beppu city	Oiat pref.
Japan	Juntendo University Hospital	Bunkyo ku	Tokyo
Japan	Hayashi Diabetes Clinic	Chigasaki city
Japan	Fukuoka University Chikushi Hospital	Chikushino city	Fukuoka pref.
Japan	Saiseikai Futsukaichi Hospital	Chikushino city	Fukuoka pref.
Japan	Yoshizaki Clinic	Chuo city	Yamanashi pref.
Japan	Hijirigaoka Hospital	Date city	Hokkaido pref.
Japan	Tsugawa Internal Medicine Clinic	Echizen city	Fukui pref.
Japan	Choei Clinic	Edogawa ku	Tokyo
Japan	Shiraishi Iin	Edogawa ku	Tokyo
Japan	Nishimura Clinic	Fujiidera city	Osaka pref.
Japan	Kuboshima Clinic	Fujisawa city	Kanagawa pref.
Japan	Takahashi Clinic	Fujisawa city	Kanagawa pref.
Japan	Fukui Chuo Clinic	Fukui city	Fukui pref.
Japan	Abies Clinic	Fukuoka city	Fukuoka pref.
Japan	Hirano Medical Clinic	Fukuoka city	Fukuoka pref.
Japan	Naitoh Clinic	Fukuoka city	Fukuoka pref.
Japan	Saku Hospital	Fukuoka city	Fukuoka pref.
Japan	Kawai Naika Clinic	Gifu city	Gifu pref.
Japan	Yamada Clinic	Gojo city	Nara pref.
Japan	Hattori Clinic	Hachioji city	Tokyo
Japan	Toyoizumi Hospital	Hachioji city	Tokyo
Japan	Utsugidai Tajima Clinic	Hachioji City	Tokyo
Japan	Kyoaikai Hospital	Hakodate city	Hokkaido pref.
Japan	Imura Internal Medicine Clinic	Hakusan city	Ishikawa pref.
Japan	Yanagi Medical Clinic	Hakusan city	Ishikawa pref.
Japan	Medimo Hanyu Clinic	Hanyu city	Saitama pref.
Japan	Yamoto-naika Clinic	Higashi matsushima city	Miyagi pref.
Japan	Ikeda Clinic	Higashiosaka city	Osaka pref.
Japan	Ogawa Clinic	Higashiosaka city	Osaka pref.
Japan	Ino Hospital	Himeji city	Hyogo pref.
Japan	Taisei Clinic	Hirakata city	Osaka pref.
Japan	Hiroshima General Hospital of West Japan Railway Company	Hiroshima city	Hiroshima pref.
Japan	Ishiga Clinic	Ibaraki city	Osaka pref.
Japan	Masuda Clinic	Ibaraki city	Osaka pref.
Japan	Kawasaki Family Clinic	Ichinoseki	Iwate pref.
Japan	Uyama Naika Clinic	Ikoma city	Nara pref.
Japan	Shimizu Clinic	Ise city	Mie pref.
Japan	Akizawa Clinic	Isehara city	Kanagawa pref.
Japan	Medical Corp Takeda Clinic	Isehara city	Kanagawa pref.
Japan	Okyozuka Clinic	Ishikawa gun	Ishikawa pref.
Japan	Mochizuki Naika Clinic	Itabashi ku	Tokyo
Japan	Nishio Clinic	Itabashi ku	Tokyo
Japan	Fukushima Clinic	Itano gun	Tokushima pref.
Japan	Yamamoto Naika Ityoka	Itano gun	Tokushima pref.
Japan	Iwasaki Naika Iin	Iwakuni city	Yamaguchi pref.
Japan	Kuwahara Clinic	Iwakuni city	Yamaguchi pref.
Japan	Sugie Clinic	Iwate gun	Iwate pref.
Japan	Matsuno Medical Clinic	Iyo gun	Ehime pref.
Japan	Kanazawa Clinic	Izumi city	Osaka pref.
Japan	Uchiyama Clinic	Joetsu city
Japan	Clinic Jinguumae	Kahihara city	Nara pref.
Japan	Kasahara Clinic	Kahihara city	Nara pref.
Japan	Koni Clinic	Kahoku gun	Ishikawa pref.
Japan	Murata Clinic	Kahoku gun	Ishikawa pref.
Japan	Yuki National Health Insurance Hospital Of Minami Town	Kaifu gun	Tokushima pref.
Japan	Misugi Clinic	Kaizuka city	Osaka pref.
Japan	Yoshida Clinic	Kaizuka city	Osaka pref.
Japan	Hashimoto Clinic	Kamakura city	Kanagawa pref.
Japan	Iroden Clinic	Kamakura city	Kanagawa pref.
Japan	Kamakura Naika Shinryosyo	Kamakura city	Kanagawa pref.
Japan	Shohei Clinic	Kamakura city	Kanagawa pref.
Japan	Nitta Medical Clinic	Kamiinagun
Japan	Koyasako iin	Kamimashiki gun	Kumamoto pref.
Japan	Arai Naika Clinic	Kanazawa city	Ishikawa pref.
Japan	Dr. Hayakawa's Family Clinic	Kanazawa city	Ishikawa pref.
Japan	Wakasa Medical Clinic	Kanazawa city	Ishikawa pref.
Japan	Osumi-Kanoya Hospital	Kanoya city	Kagoshima pref.
Japan	Sawada Clinic	Kashiba city	Nara pref.
Japan	Doi Clinic	Kashihara city	Nara pref.
Japan	Medical Corporation Kiriyama Clinic	Kashihara city	Nara pref.
Japan	Miyamoto Clinic	Kashihara city	Nara pref.
Japan	Oosumi Naika Iin	Kashihara city	Nara pref.
Japan	Fukuoka Tokushukai Medical Center	Kasuga city	Fukuoka pref.
Japan	Miyazawa Cardiovascular And Internal Medicine Clinic	Kato-gun	Hokkaido pref.
Japan	Hirose Hospital	Kawagoe city	Saitama pref.
Japan	Iryohojin Hogi Shinryojo	Kawaguchi city	Saitama pref.
Japan	Tokutake Iin	Kawaguchi city	Saitama pref.
Japan	Hatori Medical Clinic	Kawasaki city	Kanagawa pref.
Japan	Hirayasu Iin	Kawasaki city	Kanagawa pref.
Japan	Imai Clinic	Kawasaki city
Japan	Kamegaya Medical Clinic	Kawasaki city	Kanagawa pref.
Japan	Kirimura Iin	Kawasaki city	Kanagawa pref.
Japan	Kawaguchi Hospital	Kikuchi city	Kumamoto pref.
Japan	Miyamoto Internal Clinic	Kikuchi city	Kumamoto pref.
Japan	Mori Iin	Kishiwada city	Osaka pref.
Japan	Kondo Clinic Mamigaoka Purified Center	Kitakatsuragi gun	Nara pref.
Japan	Matsuoka Clinic	Kitakatsuragi gun	Nara pref.
Japan	Nakahori Iin	Kitakatsuragi gun	Nara pref.
Japan	Seiwadai Clinic	Kitakatsuragi gun	Nara pref.
Japan	Morizono Naika	Kitakyusyu city	Fukuoka pref.
Japan	Tani Clinic	Kitakyusyu City
Japan	Koide Iin	Kizugawa-city	Kyoto pref.
Japan	Kotani Diabetes Clinic	Kobe city	Hyogo pref
Japan	Shimizu Clinic	Kobe city	Hyogo pref
Japan	Ueta Medical Clinic	Kochi city	Kochi pref.
Japan	Koga Hospital	Koga city	Ibaraki pref.
Japan	Marumo Clinic	Koganei city
Japan	Morita Hospital	Komatsu city	Ishikawa pref.
Japan	Sekishinkan Hospital	Komatsushima city	Tokushima pref.
Japan	Gamo Tenjinbashi Clinic	Koshigaya city	Saitama pref.
Japan	Matsumoto Clinic	Koshigaya city	Saitama pref.
Japan	Ono Heart Clinic	Koto ku	Tokyo
Japan	Medical Corporation Shibuya Clinic	Kumagaya city	Saitama pref.
Japan	Yakushima Tokushukai Hospital	Kumage gun	Kagoshima pref.
Japan	Doi Cardiovascular Clinic	Kumamoto city	Kumamoto pref.
Japan	Doi Naika-ichoka Clinic	Kumamoto city	Kumamoto pref.
Japan	Haraguchi Circular&Internal Medical Clinic	Kumamoto city	Kumamoto pref.
Japan	Jinnouchi Clinic Diabetes Care Center	Kumamoto city	Kumamoto pref.
Japan	Kiyota Junkanki Naika Iin	Kumamoto city	Kumamoto pref.
Japan	Maki Cardiovascular Clinic	Kumamoto city	Kumamoto pref.
Japan	Nozuhara Clinic	Kumamoto city	Kumamoto pref.
Japan	Ootsuka Hospital	Kumamoto city	Kumamoto pref.
Japan	Shono Heart Clinic	Kumamoto city	Kumamoto pref.
Japan	Suefuji Naika Junkankika	Kumamoto city	Kumamoto pref.
Japan	Suizenji Tohya Hospital	Kumamoto city	Kumamoto pref.
Japan	Terao Hospital	Kumamoto city	Kumamoto pref.
Japan	Yi Medical Clinic	Kumamoto city	Kumamoto pref.
Japan	Hachiouji Naika Clinic	Kurashiki city	Okayama pref.
Japan	Inada Clinic	Kurashiki city	Okayama pref.
Japan	Seisuikai Yoshioka QQ Clinic	Kurokawa gun	Miyagi pref.
Japan	Sawai medical Clinic	Kyotanabe city	Kyoto pref.
Japan	Asamoto Clinic of Internal Medicine	Kyoto city	Kyoto pref.
Japan	Gotoh Clinic	Kyoto city	Kyoto pref.
Japan	Higashiyama Takeda Hospital	Kyoto city	Kyoto pref.
Japan	Ihara Clinic	Kyoto city
Japan	Isoda Internal Medical Clinic	Kyoto city	Kyoto pref.
Japan	Omoto Clinic	Kyoto city	Kyoto pref.
Japan	Sakazaki Clinic	Kyoto city	Kyoto pref.
Japan	Shinya Clinic	Kyoto city	Kyoto pref.
Japan	Takagi Cardiology Clinic	Kyoto city	Kyoto pref.
Japan	Takenaka Clinic	Kyoto city	Kyoto pref.
Japan	Tegoshi Clinic	Kyoto city	Kyoto pref.
Japan	Hayashi Clinic	Marugame city	Kagawa pref.
Japan	Otsuka Internal Medicine Clinic	Marugame city	Kagawa pref.
Japan	Goko-Hospital	Matsudo city
Japan	Ishite Matsumoto Naika Junkanki Clinic	Matsuyama city	Ehime pref.
Japan	Shiba Palace Clinic	Minato-ku	Tokyo
Japan	Kamada Clinic	Mitaka city	Tokyo
Japan	Tenjinmae Clinic	Mitaka city	Tokyo
Japan	Takayama Iin	Mitaka-shi	Tokyo
Japan	Satou Clinic	Moka city
Japan	Medical Corporation Joukokai Teranishi-geka naika	Moriguchi city	Osaka pref.
Japan	Katsura General Clinic	Morioka city	Iwate pref.
Japan	Sano Clinic	Murakami city	Niigata pref.
Japan	Takahashi Ko Minako Clinic	Murayama city	Yamagata pref.
Japan	Ueta Clinic	Myozai gun	Tokushima pref.
Japan	Horii Clinic Kiodai	Nabari city	Mie pref.
Japan	Kawaguchi Clinic	Nagaoka city	Niigata pref.
Japan	Hoshiko Clinic	Nagasaki city	Nagasaki pref.
Japan	Shinagawa Clinic	Nagasaki city	Nagasaki pref.
Japan	Hiramitsu Heart Clinic	Nagoya city	Aichi pref.
Japan	Medical Dock&Clinic	Nagoya city	Aichi pref.
Japan	Saiseikai Nara Hospital	Nara city	Nara pref.
Japan	Takanohara Central Hospital	Nara city	Nara pref.
Japan	Takanohara Suzuran-naika	Nara city	Nara pref.
Japan	Sugawara Clinic	Nerima ku	Tokyo
Japan	Maeda Medical Clinic	Niigata city	Niigata pref.
Japan	Ehime Medical CO-OP Izumigawa Clinic	Niihama city	Ehime pref.
Japan	Iino Clinic	Nirasaki city
Japan	Takahashi Clinic	Nishi Yatsushiro gun	Yamanashi pref.
Japan	Dr. Kodama's Office of Internal Medicine	Nishinomiya city	Hyogo pref
Japan	Iryohojin Yamamoto Naika	Nishisonogi gun	Nagasaki pref.
Japan	Obanazawa City Clinic	Obanazawa city	Yamagata pref.
Japan	Okuyama Clinic	Obanazawa city	Yamagata pref.
Japan	Sakae Clinic	Obanazawa city	Yamagata pref.
Japan	Jiyugaoka Yamada Clinic	Obihiro city	Hokkaido pref.
Japan	Kojima Clinic	Odawara city	Kanagawa pref.
Japan	Takahashi Medical Clinic	Ohtawara city	Tochigi pref.
Japan	Hirata Clinic	Oita city	Oiat pref.
Japan	Ninomiya Clinic	Oita city	Oiat pref.
Japan	Sumi Cardiology Clinic	Oita city	Oiat pref.
Japan	Tokumaru Digestive Internal Medicine Clinic	Oita city	Oiat pref.
Japan	Tsuzaki Clinic	Oita city	Oiat pref.
Japan	Hisamatsu Medical Clinic	Okayama city	Okayama pref.
Japan	Yuhara Naika Clinic	Okayama city	Okayama pref.
Japan	Iryouhoujin Suisyoukai Murata Hospital	Osaka city	Osaka pref.
Japan	Izuoka Clinic	Osaka city	Osaka pref.
Japan	Keiju Hospital	Osaka city	Osaka pref.
Japan	Kondo Clinic	Osaka city	Osaka pref.
Japan	Kubota Clinic	Osaka city	Osaka pref.
Japan	Matsushita Medical Clinic	Osaka city	Osaka pref.
Japan	Miura Clinic	Osaka City
Japan	Nishizawa Clinic	Osaka city	Osaka pref.
Japan	Osaka General Medical Center	Osaka city	Osaka pref.
Japan	Senpuku Clinic	Osaka city	Osaka pref.
Japan	Tai Internal Medicin Clinic	Osaka city	Osaka pref.
Japan	Ueda Clinic	Osaka city	Osaka pref.
Japan	Yamada Clinic	Ota-ku	Tokyo
Japan	Kuroda Iin	Otsuki City
Japan	Iryouhoujin Yuukoukai Morioka Naika Shonika	Oyama city	Tochigi pref.
Japan	Hakuai Iin	Sagamihara city	Kanagawa pref.
Japan	Sato Clinic	Sagamihara city	Kanagawa pref.
Japan	Toshiba Rinkan Hospital	Sagamihara city	Kanagawa pref.
Japan	Yamamoto Clinic	Sagamihara city	Kanagawa pref.
Japan	Akimoto Clinic	Saitama city	Saitama pref.
Japan	Iwatsuki-minami Hospital	Saitama city	Saitama pref.
Japan	Suzuhiro Clinic	Saitama city	Saitama pref.
Japan	Koshino Clinic	Sakai city	Fukui pref.
Japan	Ohta Iin	Sakai city	Osaka pref.
Japan	Honma Clinic	Sakata city	Yamagata pref.
Japan	Ote Clinic of Internal Medicine	Sakurai city	Nara pref.
Japan	Sakaguchi Clinic	Sakurai city	Nara pref.
Japan	Chikama Clinic	Sapporo city	Hokkaido pref.
Japan	Hiro Clinic	Sapporo city	Hokkaido pref.
Japan	Medical and Radiology Clinic Caress Sapporo Hokko Memorial Hospital	Sapporo city	Hokkaido pref.
Japan	Seiwa Memorial Hospital	Sapporo city	Hokkaido pref.
Japan	Sasaki Clinic	Sendai city
Japan	Matsumura Gastroenterological Clinic	Setagaya ku	Tokyo
Japan	Hattori Clinic	Setouchi city	Okayama pref.
Japan	Kamata Clinic of Internal Medicine	Shiki city
Japan	Kokuho Central Hospital	Shiki gun	Nara pref.
Japan	Nishikawa Clinic	Shimoda city
Japan	Shizuoka Medical Alliance Shirahama Chuou Clinic	Shimoda city	Shizuoka pref.
Japan	Shimoina Kosei Hospital	Shimoina gun	Nagano pref.
Japan	Satou Iin	Shimoinagun
Japan	Munakata Clinic	Shimomashiki gun	Kumamoto pref.
Japan	Ayame Medical Clinic	Shimonoseki city	Yamaguchi pref.
Japan	Johno Clinic	Shimonoseki city	Yamaguchi pref.
Japan	Matsuda Medical Clinic	Shimonoseki city	Yamaguchi pref.
Japan	Mizumachi Medical Clinic	Shimonoseki city	Yamaguchi pref.
Japan	Noda Clinic	Shimonoseki city	Yamaguchi pref.
Japan	Magari Clinic	Shinjuku ku	Tokyo
Japan	Yotsuya Internal Medicine Clinic	Shinjuku ku	Tokyo
Japan	Yotsuya-Murakami Internal Medicine Clinic	Shinjuku ku	Tokyo
Japan	Kumagai Clinic	Shinshiro city
Japan	Yokoyama Medical Clinic	Shiojiri city	Nagano pref.
Japan	Takamiya General Clinic	Shiwa gun	Iwate pref.
Japan	Akiyama Clinic	Shizuoka city	Shizuoka pref.
Japan	Aoshima Clinic	Shizuoka city	Shizuoka pref.
Japan	Eguchi Clinic	Shizuoka city	Shizuoka pref.
Japan	Shizuoka Hospital	Shizuoka city	Shizuoka pref.
Japan	Ban Clinic	Suita city	Osaka pref.
Japan	Iryohojin Nogi Naika Iin	Suita city	Osaka pref.
Japan	Kobayashi Clinic	Suita city	Osaka pref.
Japan	Obayashi Clinic	Sumida city	Tokyo
Japan	Sumidagawa Clinic	Sumida ku	Tokyo
Japan	Sato Clinic	Suzaka city	Nagano pref.
Japan	ISHII Medical Clinic	Tachikawa-shi	Tokyo
Japan	Ichida Internal Clinic	Takaishi city	Osaka pref.
Japan	Yada Clinic	Takaishi city	Osaka pref.
Japan	Center for Preventive Medical Treatment, NTT West Takamatsu Hospital	Takamatsu city	Kagawa pref.
Japan	Hananomiya Clinic	Takamatsu city	Kagawa pref.
Japan	Hasegawa Outpatients Clinic for Cardiovascular Disease	Takamatsu city	Kagawa pref.
Japan	Kojima Clinic	Takamatsu city	Kagawa pref.
Japan	Matsuoka Clinic	Takamatsu city	Kagawa pref.
Japan	Ryo Clinic	Takatsuki city	Osaka pref.
Japan	Higashi Diabetes and Cardiovascular Clinic	Tamana city	Kumamoto pref.
Japan	Yoshimura Jyunnkannkika Naika Iinn	Tamana city	Kumamoto pref.
Japan	Universal Shipbuilding Co. Ariake Shipyard Ariake Infirmary	Tamana gun	Kumamoto pref.
Japan	Takada Clinic	Tochigi city	Tochigi pref.
Japan	Nashida naika clinic	Tokorozawa City	Saitama pref.
Japan	Kensei Uchimachi Clinic	Tokushima city	Tokushima pref.
Japan	Kitagawa Naika Ityoka	Tokushima city	Tokushima pref.
Japan	Kitasako Clinic	Tokushima city	Tokushima pref.
Japan	Limbs Tokushima Clinic	Tokushima city	Tokushima pref.
Japan	Matsumura Internal, Gastrointestial Medicine	Tokushima city	Tokushima pref.
Japan	Okagawa Clinic	Tokushima city	Tokushima pref.
Japan	Yokoi Internal Medicine	Tokushima city	Tokushima pref.
Japan	Ohtomo Clinic	Tome City	Miyagi pref.
Japan	Suzuki Clinic	Toyokawa city
Japan	Higashikatsura Medical Clinic	Tsuru city	Yamanashi pref.
Japan	Fujii Clinic	Ube City	Yamaguchi pref.
Japan	Shakaiiryouhoujin Onaka Hospital	Ube City	Yamaguchi pref.
Japan	Watada-naika Hospital	Ube city	Yamaguchi pref.
Japan	Ishida Medical Clinic	Usa city	Oiat pref.
Japan	Masuda Naika	Utsunomiya city	Tochigi pref.
Japan	Ueno Clinic	Yaizu city	Shizuoka pref.
Japan	Benibana Clinic	Yamagata city
Japan	Isoda Clinic	Yamagata city	Yamagata pref.
Japan	Nihei Clinic	Yamagata city	Yamagata pref.
Japan	Shimasaki Clinic	Yamagata city	Yamagata pref.
Japan	Yamagata Tokushukai Hospital	Yamagata city	Yamagata pref.
Japan	Ouchi Clinic	Yamaguchi city	Yamaguchi pref.
Japan	Makiura Naika	Yamatokoriyama city	Nara pref.
Japan	Matsuta Heart Clinic	Yamatokoriyama city	Nara pref.
Japan	Nakatani Clinic	Yamatotakada city	Nara pref.
Japan	Matsuo Clinic	Yao city	Osaka pref.
Japan	Miyagi Clinic Cardiovascular Medicine	Yatsushiro city	Kumamoto pref.
Japan	Fujimi Clinic	Yokohama city
Japan	Fukumura Clinic	Yokohama city	Kanagawa pref.
Japan	Fukushi Clinic	Yokohama city	Kanagawa pref.
Japan	Hongo Clinic	Yokohama city
Japan	International Goodwill Hospital	Yokohama city	Kanagawa pref.
Japan	Jiyukai Yamada Naika	Yokohama city
Japan	Kikuchi Clinic	Yokohama city	Kanagawa pref.
Japan	Matsuo Naika Clinic	Yokohama city	Kanagawa pref.
Japan	Miho-cho Cardiovascular Medical Clinic	Yokohama city	Kanagawa pref.
Japan	Minamisawa Clinic	Yokohama city	Kanagawa pref.
Japan	Miyoshi-Clinic	Yokohama city	Kanagawa pref.
Japan	Paula's Clinic	Yokohama city	Kanagawa pref.
Japan	Shimokurata Heart Clinic	Yokohama city	Kanagawa pref.
Japan	Shinwakai Fukuda Iin	Yokohama city	Kanagawa pref.
Japan	Shinyoshida Clinic	Yokohama city	Kanagawa pref.
Japan	Shonan Ochanomizu Clinic	Yokohama city
Japan	Suzuki Orthopedic Clinic	Yokohama city	Kanagawa pref.
Japan	Tani Clinic Internal Medicine, Allergology & Rheumatology	Yokohama city
Japan	Yokohama City University Medical Center	Yokohama city	Kanagawa pref.
Japan	Yokohama Sotetsu bldg. clinic of internal medicine	Yokohama city	Kanagawa pref.
Japan	Hara Clinic	Yokosuka City	Kanagawa pref.
Japan	Kimura Naika Clinic	Yosa gun	Kyoto pref.
Japan	Kimura Internal Medicine Clinic	Yoshinokawa city	Tokushima pref.
Japan	Yata Clinic	Yoshinokawa city	Tokushima pref.
Japan	Medical Treatment Corporate Foundation Yubari Kibounomori Yubari City Clinic	Yubari city	Hokkaido pref.

Sponsors (1)

Lead Sponsor	Collaborator
Positive Trial Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event		At baseline	No
Primary	MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event		1 month after treatment initiation	No
Primary	MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event		3 month after treatment initiation	No
Primary	MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event		6 month after treatment initiation	No
Primary	MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event		12 month after treatment initiation	No
Primary	MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event		36 month after treatment initiation	No
Primary	MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event		At the end of the study or discontinuation up to 4 years	No
Secondary	Prevention of individual MACE		At baseline	Yes
Secondary	Prevention of MACE(combination of each category)		At baseline	Yes
Secondary	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)		At baseline	Yes
Secondary	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")		At baseline	Yes
Secondary	Frequency and distribution of type of deaths during the study period		At baseline	Yes
Secondary	Frequency and distribution of type of hospitalizations during the study period		At baseline	Yes
Secondary	Frequency of other events (malignancy, dementia, need of nursing care)		At baseline	Yes
Secondary	Frequency and type of adverse events		At baseline	Yes
Secondary	Prevention of individual MACE		1 month after treatment initiation	Yes
Secondary	Prevention of individual MACE		3 month after treatment initiation	Yes
Secondary	Prevention of individual MACE		6 month after treatment initiation	Yes
Secondary	Prevention of individual MACE		12 month after treatment initiation	Yes
Secondary	Prevention of individual MACE		36 month after treatment initiation	Yes
Secondary	Prevention of individual MACE		At the end of the study (or discontinuation)	Yes
Secondary	Prevention of MACE(combination of each category)		1 month after treatment initiation	Yes
Secondary	Prevention of MACE(combination of each category)		3 month after treatment initiation	Yes
Secondary	Prevention of MACE(combination of each category)		6 month after treatment initiation	Yes
Secondary	Prevention of MACE(combination of each category)		12 month after treatment initiation	Yes
Secondary	Prevention of MACE(combination of each category)		36 month after treatment initiation	Yes
Secondary	Prevention of MACE(combination of each category)		At the end of the study (or discontinuation)	Yes
Secondary	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)		1 month after treatment initiation	Yes
Secondary	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)		3 month after treatment initiation	Yes
Secondary	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)		6 month after treatment initiation	Yes
Secondary	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)		12 month after treatment initiation	Yes
Secondary	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)		36 month after treatment initiation	Yes
Secondary	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)		At study completion up to 4 years	Yes
Secondary	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")		1 month after treatment initiation	Yes
Secondary	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")		3 month after treatment initiation	Yes
Secondary	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")		6 month after treatment initiation	Yes
Secondary	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")		12 month after treatment initiation	Yes
Secondary	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")		36 month after treatment initiation	Yes
Secondary	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")		At the end of the study or discontinuation up to 4 years	Yes
Secondary	Frequency and distribution of type of deaths during the study period		1 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of deaths during the study period		3 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of deaths during the study period		6 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of deaths during the study period		12 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of deaths during the study period		36 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of deaths during the study period		At the end of the study or discontinuation up to 4 years	Yes
Secondary	Frequency and distribution of type of hospitalizations during the study period		1 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of hospitalizations during the study period		3 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of hospitalizations during the study period		6 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of hospitalizations during the study period		12 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of hospitalizations during the study period		36 month after treatment initiation	Yes
Secondary	Frequency and distribution of type of hospitalizations during the study period		At the end of the study or discontinuation up to 4 years	Yes
Secondary	Frequency of other events (malignancy, dementia, need of nursing care)		1 month after treatment initiation	Yes
Secondary	Frequency of other events (malignancy, dementia, need of nursing care)		3 month after treatment initiation	Yes
Secondary	Frequency of other events (malignancy, dementia, need of nursing care)		6 month after treatment initiation	Yes
Secondary	Frequency of other events (malignancy, dementia, need of nursing care)		12 month after treatment initiation	Yes
Secondary	Frequency of other events (malignancy, dementia, need of nursing care)		36 month after treatment initiation	Yes
Secondary	Frequency of other events (malignancy, dementia, need of nursing care)		At the end of the study or discontinuation up to 4 years	Yes
Secondary	Frequency and type of adverse events		1 month after treatment initiation	Yes
Secondary	Frequency and type of adverse events		3 month after treatment initiation	No
Secondary	Frequency and type of adverse events		6 month after treatment initiation	Yes
Secondary	Frequency and type of adverse events		12 month after treatment initiation	Yes
Secondary	Frequency and type of adverse events		36 month after treatment initiation	Yes
Secondary	Frequency and type of adverse events		At the end of the study or discontinuation up to 4 years	Yes