AzTrials
AzTrials

HypercholesterolemiaPOSITIVENCT01173939

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

A study testing Pravastatin and Rosuvastatin in people with Hypercholesterolemia and Type 2 Diabetes, run by Positive Trial Group at 317 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Pravastatin and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,000 participants
Where
317 sitesJapan
Study dates
Jul 2010to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

317 sites in 1 country.

300 sites in 1 country

Japan300 sites

  • Enomoto Clinic

    Ageo, Saitama Pref.

  • Okubo Clinic

    Akishima, Tokyo

  • Katsuya Clinic

    Amagasaki, Hyogo Pref

  • Nakayama Cardiovascular Clinic

    Amakusa, Kumamoto Pref.

  • Yamashita Clinic

    Amakusa, Kumamoto Pref.

  • Murakami Clinic

    Anan, Tokushima Pref.

  • Fukushi Clinic

    Aomori

  • Nemoto G.I.M. Clinic

    Ashigara-kami Gun, Kanagawa Pref.

  • Magokoro Internal Medicine and Orthopedic Clinic

    Ashigarakami Gun, Kanagawa Pref.

  • National Health Insurance Central Hospital Aso

    Aso, Kumamoto Pref.

  • Sakanashi Heart Clinic

    Aso, Kumamoto Pref.

  • Kasuya Clinic

    Atsugi, Kanagawa Pref.

  • Kashiwagi Clinic

    Ayase

  • Watanabe NJ Clinic

    Beppu, Oiat Pref.

  • Juntendo University Hospital

    Bunkyo Ku, Tokyo

  • Hayashi Diabetes Clinic

    Chigasaki

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka Pref.

  • Saiseikai Futsukaichi Hospital

    Chikushino-shi, Fukuoka Pref.

  • Yoshizaki Clinic

    Chūō, Yamanashi Pref.

  • Hijirigaoka Hospital

    Date, Hokkaido Pref.

  • Tsugawa Internal Medicine Clinic

    Echizen, Fukui Pref.

  • Choei Clinic

    Edogawa Ku, Tokyo

  • Shiraishi Iin

    Edogawa Ku, Tokyo

  • Nishimura Clinic

    Fujiidera, Osaka Pref.

  • Kuboshima Clinic

    Fujisawa, Kanagawa Pref.

  • Takahashi Clinic

    Fujisawa, Kanagawa Pref.

  • Fukui Chuo Clinic

    Fukui, Fukui Pref.

  • Abies Clinic

    Fukuoka, Fukuoka Pref.

  • Hirano Medical Clinic

    Fukuoka, Fukuoka Pref.

  • Naitoh Clinic

    Fukuoka, Fukuoka Pref.

  • Saku Hospital

    Fukuoka, Fukuoka Pref.

  • Kawai Naika Clinic

    Gifu, Gifu Pref.

  • Yamada Clinic

    Gojō, Nara Pref.

  • Hattori Clinic

    Hachiōji, Tokyo

  • Toyoizumi Hospital

    Hachiōji, Tokyo

  • Utsugidai Tajima Clinic

    Hachiōji, Tokyo

  • Kyoaikai Hospital

    Hakodate, Hokkaido Pref.

  • Imura Internal Medicine Clinic

    Hakusan, Ishikawa Pref.

  • Yanagi Medical Clinic

    Hakusan, Ishikawa Pref.

  • Medimo Hanyu Clinic

    Hanyū, Saitama Pref.

  • Yamoto-naika Clinic

    Higashi Matsushima City, Miyagi Pref.

  • Ikeda Clinic

    Higashiosaka, Osaka Pref.

  • Ogawa Clinic

    Higashiosaka, Osaka Pref.

  • Ino Hospital

    Himeji, Hyogo Pref.

  • Taisei Clinic

    Hirakata, Osaka Pref.

  • Hiroshima General Hospital of West Japan Railway Company

    Hiroshima, Hiroshima Pref.

  • Ishiga Clinic

    Ibaraki, Osaka Pref.

  • Masuda Clinic

    Ibaraki, Osaka Pref.

  • Kawasaki Family Clinic

    Ichinoseki, Iwate Pref.

  • Uyama Naika Clinic

    Ikoma, Nara Pref.

  • Shimizu Clinic

    Ise, Mie Pref.

  • Akizawa Clinic

    Isehara, Kanagawa Pref.

  • Medical Corp Takeda Clinic

    Isehara, Kanagawa Pref.

  • Okyozuka Clinic

    Ishikawa Gun, Ishikawa Pref.

  • Fukushima Clinic

    Itano Gun, Tokushima Pref.

  • Yamamoto Naika Ityoka

    Itano Gun, Tokushima Pref.

  • Iwasaki Naika Iin

    Iwakuni, Yamaguchi Pref.

  • Kuwahara Clinic

    Iwakuni, Yamaguchi Pref.

  • Sugie Clinic

    Iwate Gun, Iwate Pref.

  • Matsuno Medical Clinic

    Iyo Gun, Ehime Pref.

  • Kanazawa Clinic

    Izumi, Osaka Pref.

  • Uchiyama Clinic

    Jōetsu

  • Clinic Jinguumae

    Kahihara City, Nara Pref.

  • Kasahara Clinic

    Kahihara City, Nara Pref.

  • Koni Clinic

    Kahoku Gun, Ishikawa Pref.

  • Murata Clinic

    Kahoku Gun, Ishikawa Pref.

  • Yuki National Health Insurance Hospital Of Minami Town

    Kaifu Gun, Tokushima Pref.

  • Misugi Clinic

    Kaizuka, Osaka Pref.

  • Yoshida Clinic

    Kaizuka, Osaka Pref.

  • Hashimoto Clinic

    Kamakura, Kanagawa Pref.

  • Iroden Clinic

    Kamakura, Kanagawa Pref.

  • Kamakura Naika Shinryosyo

    Kamakura, Kanagawa Pref.

  • Shohei Clinic

    Kamakura, Kanagawa Pref.

  • Nitta Medical Clinic

    Kamiinagun

  • Koyasako iin

    Kamimashiki Gun, Kumamoto Pref.

  • Arai Naika Clinic

    Kanazawa, Ishikawa Pref.

  • Dr. Hayakawa's Family Clinic

    Kanazawa, Ishikawa Pref.

  • Wakasa Medical Clinic

    Kanazawa, Ishikawa Pref.

  • Osumi-Kanoya Hospital

    Kanoya, Kagoshima Pref.

  • Sawada Clinic

    Kashiba, Nara Pref.

  • Doi Clinic

    Kashihara, Nara Pref.

  • Medical Corporation Kiriyama Clinic

    Kashihara, Nara Pref.

  • Miyamoto Clinic

    Kashihara, Nara Pref.

  • Oosumi Naika Iin

    Kashihara, Nara Pref.

  • Fukuoka Tokushukai Medical Center

    Kasuga, Fukuoka Pref.

  • Miyazawa Cardiovascular And Internal Medicine Clinic

    Kato-gun, Hokkaido Pref.

  • Hirose Hospital

    Kawagoe, Saitama Pref.

  • Iryohojin Hogi Shinryojo

    Kawaguchi, Saitama Pref.

  • Tokutake Iin

    Kawaguchi, Saitama Pref.

  • Hatori Medical Clinic

    Kawasaki, Kanagawa Pref.

  • Hirayasu Iin

    Kawasaki, Kanagawa Pref.

  • Kamegaya Medical Clinic

    Kawasaki, Kanagawa Pref.

  • Kirimura Iin

    Kawasaki, Kanagawa Pref.

  • Imai Clinic

    Kawasaki

  • Kawaguchi Hospital

    Kikuchi, Kumamoto Pref.

  • Miyamoto Internal Clinic

    Kikuchi, Kumamoto Pref.

  • Mori Iin

    Kishiwada, Osaka Pref.

  • Kondo Clinic Mamigaoka Purified Center

    Kitakatsuragi Gun, Nara Pref.

  • Matsuoka Clinic

    Kitakatsuragi Gun, Nara Pref.

  • Nakahori Iin

    Kitakatsuragi Gun, Nara Pref.

  • Seiwadai Clinic

    Kitakatsuragi Gun, Nara Pref.

  • Morizono Naika

    Kitakyushu, Fukuoka Pref.

  • Tani Clinic

    Kitakyushu

  • Koide Iin

    Kizugawa, Kyoto Pref.

  • Kotani Diabetes Clinic

    Kobe, Hyogo Pref

  • Shimizu Clinic

    Kobe, Hyogo Pref

  • Ueta Medical Clinic

    Kochi, Kochi Pref.

  • Koga Hospital

    Koga, Ibaraki Pref.

  • Marumo Clinic

    Koganei

  • Morita Hospital

    Komatsu, Ishikawa Pref.

  • Sekishinkan Hospital

    Komatsushima, Tokushima Pref.

  • Gamo Tenjinbashi Clinic

    Koshigaya, Saitama Pref.

  • Matsumoto Clinic

    Koshigaya, Saitama Pref.

  • Ono Heart Clinic

    Koto Ku, Tokyo

  • Medical Corporation Shibuya Clinic

    Kumagaya, Saitama Pref.

  • Yakushima Tokushukai Hospital

    Kumage Gun, Kagoshima Pref.

  • Doi Cardiovascular Clinic

    Kumamoto, Kumamoto Pref.

  • Doi Naika-ichoka Clinic

    Kumamoto, Kumamoto Pref.

  • Haraguchi Circular&Internal Medical Clinic

    Kumamoto, Kumamoto Pref.

  • Jinnouchi Clinic Diabetes Care Center

    Kumamoto, Kumamoto Pref.

  • Kiyota Junkanki Naika Iin

    Kumamoto, Kumamoto Pref.

  • Maki Cardiovascular Clinic

    Kumamoto, Kumamoto Pref.

  • Nozuhara Clinic

    Kumamoto, Kumamoto Pref.

  • Ootsuka Hospital

    Kumamoto, Kumamoto Pref.

  • Shono Heart Clinic

    Kumamoto, Kumamoto Pref.

  • Suefuji Naika Junkankika

    Kumamoto, Kumamoto Pref.

  • Suizenji Tohya Hospital

    Kumamoto, Kumamoto Pref.

  • Terao Hospital

    Kumamoto, Kumamoto Pref.

  • Yi Medical Clinic

    Kumamoto, Kumamoto Pref.

  • Hachiouji Naika Clinic

    Kurashiki, Okayama Pref.

  • Inada Clinic

    Kurashiki, Okayama Pref.

  • Seisuikai Yoshioka QQ Clinic

    Kurokawa Gun, Miyagi Pref.

  • Sawai medical Clinic

    Kyōtanabe, Kyoto Pref.

  • Asamoto Clinic of Internal Medicine

    Kyoto, Kyoto Pref.

  • Gotoh Clinic

    Kyoto, Kyoto Pref.

  • Higashiyama Takeda Hospital

    Kyoto, Kyoto Pref.

  • Isoda Internal Medical Clinic

    Kyoto, Kyoto Pref.

  • Omoto Clinic

    Kyoto, Kyoto Pref.

  • Sakazaki Clinic

    Kyoto, Kyoto Pref.

  • Shinya Clinic

    Kyoto, Kyoto Pref.

  • Takagi Cardiology Clinic

    Kyoto, Kyoto Pref.

  • Takenaka Clinic

    Kyoto, Kyoto Pref.

  • Tegoshi Clinic

    Kyoto, Kyoto Pref.

  • Ihara Clinic

    Kyoto

  • Hayashi Clinic

    Marugame, Kagawa Pref.

  • Otsuka Internal Medicine Clinic

    Marugame, Kagawa Pref.

  • Goko-Hospital

    Matsudo

  • Ishite Matsumoto Naika Junkanki Clinic

    Matsuyama, Ehime Pref.

  • Shiba Palace Clinic

    Minato-ku, Tokyo

  • Kamada Clinic

    Mitaka, Tokyo

  • Tenjinmae Clinic

    Mitaka, Tokyo

  • Takayama Iin

    Mitaka-shi, Tokyo

  • Satou Clinic

    Mooka

  • Medical Corporation Joukokai Teranishi-geka naika

    Moriguchi, Osaka Pref.

  • Katsura General Clinic

    Morioka, Iwate Pref.

  • Sano Clinic

    Murakami, Niigata Pref.

  • Takahashi Ko Minako Clinic

    Murayama, Yamagata Pref.

  • Ueta Clinic

    Myozai Gun, Tokushima Pref.

  • Horii Clinic Kiodai

    Nabari, Mie Pref.

  • Kawaguchi Clinic

    Nagaoka, Niigata Pref.

  • Hoshiko Clinic

    Nagasaki, Nagasaki Pref.

  • Shinagawa Clinic

    Nagasaki, Nagasaki Pref.

  • Hiramitsu Heart Clinic

    Nagoya, Aichi Pref.

  • Medical Dock&Clinic

    Nagoya, Aichi Pref.

  • Saiseikai Nara Hospital

    Nara, Nara Pref.

  • Takanohara Central Hospital

    Nara, Nara Pref.

  • Takanohara Suzuran-naika

    Nara, Nara Pref.

  • Sugawara Clinic

    Nerima Ku, Tokyo

  • Maeda Medical Clinic

    Niigata, Niigata Pref.

  • Ehime Medical CO-OP Izumigawa Clinic

    Niihama, Ehime Pref.

  • Iino Clinic

    Nirasaki

  • Takahashi Clinic

    Nishi Yatsushiro Gun, Yamanashi Pref.

  • Dr. Kodama's Office of Internal Medicine

    Nishinomiya, Hyogo Pref

  • Iryohojin Yamamoto Naika

    Nishisonogi Gun, Nagasaki Pref.

  • Obanazawa City Clinic

    Obanazawa, Yamagata Pref.

  • Okuyama Clinic

    Obanazawa, Yamagata Pref.

  • Sakae Clinic

    Obanazawa, Yamagata Pref.

  • Jiyugaoka Yamada Clinic

    Obihiro, Hokkaido Pref.

  • Kojima Clinic

    Odawara, Kanagawa Pref.

  • Takahashi Medical Clinic

    Ohtawara City, Tochigi Pref.

  • Hirata Clinic

    Ōita, Oiat Pref.

  • Ninomiya Clinic

    Ōita, Oiat Pref.

  • Sumi Cardiology Clinic

    Ōita, Oiat Pref.

  • Tokumaru Digestive Internal Medicine Clinic

    Ōita, Oiat Pref.

  • Tsuzaki Clinic

    Ōita, Oiat Pref.

  • Hisamatsu Medical Clinic

    Okayama, Okayama Pref.

  • Yuhara Naika Clinic

    Okayama, Okayama Pref.

  • Iryouhoujin Suisyoukai Murata Hospital

    Osaka, Osaka Pref.

  • Izuoka Clinic

    Osaka, Osaka Pref.

  • Keiju Hospital

    Osaka, Osaka Pref.

  • Kondo Clinic

    Osaka, Osaka Pref.

  • Kubota Clinic

    Osaka, Osaka Pref.

  • Matsushita Medical Clinic

    Osaka, Osaka Pref.

  • Nishizawa Clinic

    Osaka, Osaka Pref.

  • Osaka General Medical Center

    Osaka, Osaka Pref.

  • Senpuku Clinic

    Osaka, Osaka Pref.

  • Tai Internal Medicin Clinic

    Osaka, Osaka Pref.

  • Ueda Clinic

    Osaka, Osaka Pref.

  • Miura Clinic

    Osaka

  • Yamada Clinic

    Ōta-ku, Tokyo

  • Kuroda Iin

    Ōtsuki

  • Iryouhoujin Yuukoukai Morioka Naika Shonika

    Oyama, Tochigi Pref.

  • Hakuai Iin

    Sagamihara, Kanagawa Pref.

  • Sato Clinic

    Sagamihara, Kanagawa Pref.

  • Toshiba Rinkan Hospital

    Sagamihara, Kanagawa Pref.

  • Yamamoto Clinic

    Sagamihara, Kanagawa Pref.

  • Akimoto Clinic

    Saitama, Saitama Pref.

  • Iwatsuki-minami Hospital

    Saitama, Saitama Pref.

  • Suzuhiro Clinic

    Saitama, Saitama Pref.

  • Koshino Clinic

    Sakai, Fukui Pref.

  • Ohta Iin

    Sakai, Osaka Pref.

  • Honma Clinic

    Sakata, Yamagata Pref.

  • Ote Clinic of Internal Medicine

    Sakurai, Nara Pref.

  • Sakaguchi Clinic

    Sakurai, Nara Pref.

  • Chikama Clinic

    Sapporo, Hokkaido Pref.

  • Hiro Clinic

    Sapporo, Hokkaido Pref.

  • Medical and Radiology Clinic Caress Sapporo Hokko Memorial Hospital

    Sapporo, Hokkaido Pref.

  • Seiwa Memorial Hospital

    Sapporo, Hokkaido Pref.

  • Sasaki Clinic

    Sendai

  • Matsumura Gastroenterological Clinic

    Setagaya Ku, Tokyo

  • Hattori Clinic

    Setouchi, Okayama Pref.

  • Kamata Clinic of Internal Medicine

    Shiki

  • Kokuho Central Hospital

    Shiki Gun, Nara Pref.

  • Shizuoka Medical Alliance Shirahama Chuou Clinic

    Shimoda, Shizuoka Pref.

  • Nishikawa Clinic

    Shimoda

  • Shimoina Kosei Hospital

    Shimoina Gun, Nagano Pref.

  • Satou Iin

    Shimoinagun

  • Munakata Clinic

    Shimomashiki Gun, Kumamoto Pref.

  • Ayame Medical Clinic

    Shimonoseki, Yamaguchi Pref.

  • Johno Clinic

    Shimonoseki, Yamaguchi Pref.

  • Matsuda Medical Clinic

    Shimonoseki, Yamaguchi Pref.

  • Mizumachi Medical Clinic

    Shimonoseki, Yamaguchi Pref.

  • Noda Clinic

    Shimonoseki, Yamaguchi Pref.

  • Magari Clinic

    Shinjuku Ku, Tokyo

  • Yotsuya Internal Medicine Clinic

    Shinjuku Ku, Tokyo

  • Yotsuya-Murakami Internal Medicine Clinic

    Shinjuku Ku, Tokyo

  • Kumagai Clinic

    Shinshiro

  • Yokoyama Medical Clinic

    Shiojiri, Nagano Pref.

  • Takamiya General Clinic

    Shiwa Gun, Iwate Pref.

  • Akiyama Clinic

    Shizuoka, Shizuoka Pref.

  • Aoshima Clinic

    Shizuoka, Shizuoka Pref.

  • Eguchi Clinic

    Shizuoka, Shizuoka Pref.

  • Shizuoka Hospital

    Shizuoka, Shizuoka Pref.

  • Ban Clinic

    Suita, Osaka Pref.

  • Iryohojin Nogi Naika Iin

    Suita, Osaka Pref.

  • Kobayashi Clinic

    Suita, Osaka Pref.

  • Obayashi Clinic

    Sumida City, Tokyo

  • Sumidagawa Clinic

    Sumida Ku, Tokyo

  • Sato Clinic

    Suzaka, Nagano Pref.

  • Mochizuki Naika Clinic

    tabashi City, Tokyo

  • Nishio Clinic

    tabashi City, Tokyo

  • ISHII Medical Clinic

    Tachikawa-shi, Tokyo

  • Ichida Internal Clinic

    Takaishi, Osaka Pref.

  • Yada Clinic

    Takaishi, Osaka Pref.

  • Center for Preventive Medical Treatment, NTT West Takamatsu Hospital

    Takamatsu, Kagawa Pref.

  • Hananomiya Clinic

    Takamatsu, Kagawa Pref.

  • Hasegawa Outpatients Clinic for Cardiovascular Disease

    Takamatsu, Kagawa Pref.

  • Kojima Clinic

    Takamatsu, Kagawa Pref.

  • Matsuoka Clinic

    Takamatsu, Kagawa Pref.

  • Ryo Clinic

    Takatsuki, Osaka Pref.

  • Higashi Diabetes and Cardiovascular Clinic

    Tamana, Kumamoto Pref.

  • Yoshimura Jyunnkannkika Naika Iinn

    Tamana, Kumamoto Pref.

  • Universal Shipbuilding Co. Ariake Shipyard Ariake Infirmary

    Tamana Gun, Kumamoto Pref.

  • Takada Clinic

    Tochigi, Tochigi Pref.

  • Nashida naika clinic

    Tokorozawa, Saitama Pref.

  • Kensei Uchimachi Clinic

    Tokushima, Tokushima Pref.

  • Kitagawa Naika Ityoka

    Tokushima, Tokushima Pref.

  • Kitasako Clinic

    Tokushima, Tokushima Pref.

  • Limbs Tokushima Clinic

    Tokushima, Tokushima Pref.

  • Matsumura Internal, Gastrointestial Medicine

    Tokushima, Tokushima Pref.

  • Okagawa Clinic

    Tokushima, Tokushima Pref.

  • Yokoi Internal Medicine

    Tokushima, Tokushima Pref.

  • Ohtomo Clinic

    Tome, Miyagi Pref.

  • Suzuki Clinic

    Toyokawa

  • Higashikatsura Medical Clinic

    Tsuru, Yamanashi Pref.

  • Fujii Clinic

    Ube, Yamaguchi Pref.

  • Shakaiiryouhoujin Onaka Hospital

    Ube, Yamaguchi Pref.

  • Watada-naika Hospital

    Ube, Yamaguchi Pref.

  • Ishida Medical Clinic

    Usa, Oiat Pref.

  • Masuda Naika

    Utsunomiya, Tochigi Pref.

  • Ueno Clinic

    Yaizu, Shizuoka Pref.

  • Isoda Clinic

    Yamagata, Yamagata Pref.

  • Nihei Clinic

    Yamagata, Yamagata Pref.

  • Shimasaki Clinic

    Yamagata, Yamagata Pref.

  • Yamagata Tokushukai Hospital

    Yamagata, Yamagata Pref.

  • Benibana Clinic

    Yamagata

  • Ouchi Clinic

    Yamaguchi, Yamaguchi Pref.

  • Makiura Naika

    Yamatokōriyama, Nara Pref.

  • Matsuta Heart Clinic

    Yamatokōriyama, Nara Pref.

  • Nakatani Clinic

    Yamatotakada City, Nara Pref.

  • Matsuo Clinic

    Yao, Osaka Pref.

  • Miyagi Clinic Cardiovascular Medicine

    Yatsushiro, Kumamoto Pref.

  • Fukumura Clinic

    Yokohama, Kanagawa Pref.

  • Fukushi Clinic

    Yokohama, Kanagawa Pref.

  • International Goodwill Hospital

    Yokohama, Kanagawa Pref.

  • Kikuchi Clinic

    Yokohama, Kanagawa Pref.

  • Matsuo Naika Clinic

    Yokohama, Kanagawa Pref.

  • Miho-cho Cardiovascular Medical Clinic

    Yokohama, Kanagawa Pref.

  • Minamisawa Clinic

    Yokohama, Kanagawa Pref.

  • Miyoshi-Clinic

    Yokohama, Kanagawa Pref.

Other trials in Japan

About this study

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

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.

Being tested
Pravastatin, Rosuvastatin
Keywords
Hypercholesterolemia with concomitant type 2 diabetes and hypertension
Medical subject headings
Hypercholesterolemia, Diabetes Mellitus, Type 2, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PravastatinDrug

    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)

  • RosuvastatinDrug

    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)

Study groups in NCT01173939
Study groupRoleWhat they receive
Active comparator: Standard Pravastatin GroupActive comparatorNot described
Receives: Drug: Pravastatin
Intensive Rosuvastatin GroupActive comparatorNot described
Receives: Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At baseline

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

    Measured: 1 month after treatment initiation

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

    Measured: 3 month after treatment initiation

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

    Measured: 6 month after treatment initiation

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

    Measured: 12 month after treatment initiation

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

    Measured: 36 month after treatment initiation

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

    Measured: At the end of the study or discontinuation up to 4 years

Secondary outcomes (56)

  1. Prevention of individual MACE

    Measured: At baseline

  2. Prevention of MACE(combination of each category)

    Measured: At baseline

  3. 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)

    Measured: At baseline

  4. 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")

    Measured: At baseline

  5. Frequency and distribution of type of deaths during the study period

    Measured: At baseline

  6. Frequency and distribution of type of hospitalizations during the study period

    Measured: At baseline

  7. Frequency of other events (malignancy, dementia, need of nursing care)

    Measured: At baseline

  8. Frequency and type of adverse events

    Measured: At baseline

  9. Prevention of individual MACE

    Measured: 1 month after treatment initiation

  10. Prevention of individual MACE

    Measured: 3 month after treatment initiation

  11. Prevention of individual MACE

    Measured: 6 month after treatment initiation

  12. Prevention of individual MACE

    Measured: 12 month after treatment initiation

  13. Prevention of individual MACE

    Measured: 36 month after treatment initiation

  14. Prevention of individual MACE

    Measured: At the end of the study (or discontinuation)

  15. Prevention of MACE(combination of each category)

    Measured: 1 month after treatment initiation

  16. Prevention of MACE(combination of each category)

    Measured: 3 month after treatment initiation

  17. Prevention of MACE(combination of each category)

    Measured: 6 month after treatment initiation

  18. Prevention of MACE(combination of each category)

    Measured: 12 month after treatment initiation

  19. Prevention of MACE(combination of each category)

    Measured: 36 month after treatment initiation

  20. Prevention of MACE(combination of each category)

    Measured: At the end of the study (or discontinuation)

  21. 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)

    Measured: 1 month after treatment initiation

  22. 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)

    Measured: 3 month after treatment initiation

  23. 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)

    Measured: 6 month after treatment initiation

  24. 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)

    Measured: 12 month after treatment initiation

  25. 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)

    Measured: 36 month after treatment initiation

  26. 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)

    Measured: At study completion up to 4 years

  27. 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")

    Measured: 1 month after treatment initiation

  28. 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")

    Measured: 3 month after treatment initiation

  29. 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")

    Measured: 6 month after treatment initiation

  30. 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")

    Measured: 12 month after treatment initiation

  31. 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")

    Measured: 36 month after treatment initiation

  32. 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")

    Measured: At the end of the study or discontinuation up to 4 years

  33. Frequency and distribution of type of deaths during the study period

    Measured: 1 month after treatment initiation

  34. Frequency and distribution of type of deaths during the study period

    Measured: 3 month after treatment initiation

  35. Frequency and distribution of type of deaths during the study period

    Measured: 6 month after treatment initiation

  36. Frequency and distribution of type of deaths during the study period

    Measured: 12 month after treatment initiation

  37. Frequency and distribution of type of deaths during the study period

    Measured: 36 month after treatment initiation

  38. Frequency and distribution of type of deaths during the study period

    Measured: At the end of the study or discontinuation up to 4 years

  39. Frequency and distribution of type of hospitalizations during the study period

    Measured: 1 month after treatment initiation

  40. Frequency and distribution of type of hospitalizations during the study period

    Measured: 3 month after treatment initiation

  41. Frequency and distribution of type of hospitalizations during the study period

    Measured: 6 month after treatment initiation

  42. Frequency and distribution of type of hospitalizations during the study period

    Measured: 12 month after treatment initiation

  43. Frequency and distribution of type of hospitalizations during the study period

    Measured: 36 month after treatment initiation

  44. Frequency and distribution of type of hospitalizations during the study period

    Measured: At the end of the study or discontinuation up to 4 years

  45. Frequency of other events (malignancy, dementia, need of nursing care)

    Measured: 1 month after treatment initiation

  46. Frequency of other events (malignancy, dementia, need of nursing care)

    Measured: 3 month after treatment initiation

  47. Frequency of other events (malignancy, dementia, need of nursing care)

    Measured: 6 month after treatment initiation

  48. Frequency of other events (malignancy, dementia, need of nursing care)

    Measured: 12 month after treatment initiation

  49. Frequency of other events (malignancy, dementia, need of nursing care)

    Measured: 36 month after treatment initiation

  50. Frequency of other events (malignancy, dementia, need of nursing care)

    Measured: At the end of the study or discontinuation up to 4 years

  51. Frequency and type of adverse events

    Measured: 1 month after treatment initiation

  52. Frequency and type of adverse events

    Measured: 3 month after treatment initiation

  53. Frequency and type of adverse events

    Measured: 6 month after treatment initiation

  54. Frequency and type of adverse events

    Measured: 12 month after treatment initiation

  55. Frequency and type of adverse events

    Measured: 36 month after treatment initiation

  56. Frequency and type of adverse events

    Measured: At the end of the study or discontinuation up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionJun 2014 (estimated)

Why it stopped: With recommendation from IDMC, Steering Committee terminated this trial due to ethical concerns raised by J-ART study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01173939
Sponsor's protocol ID
0035
Acronym
POSITIVE
Status last verified
Nov 2010
First submitted
27 Jul 2010
Last updated
1 Jun 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Pravastatin and Rosuvastatin in people with Hypercholesterolemia and Type 2 Diabetes, run by Positive Trial Group at 317 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 317 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: With recommendation from IDMC, Steering Committee terminated this trial due to ethical concerns raised by J-ART study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01173939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.

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