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Acarbose Cardiovascular Evaluation Trial (ACE)

21 июля 2017 г. обновлено: University of Oxford

A Long-term, Multicentre, Double-blind, Randomised Parallel-group Trial to Determine Whether Reducing Post-prandial Glycaemia Can Reduce Cardiovascular-related Morbidity and Mortality in Patients With Established Coronary Heart Disease or Acute Coronary Syndrome Who Have Impaired Glucose Tolerance

The purpose of this study is to determine whether acarbose therapy can reduce cardiovascular-related morbidity and mortality in patients with impaired glucose tolerance (IGT) who have established coronary heart disease (CHD) or acute coronary syndrome (ACS). A secondary objective of the study is to determine if acarbose therapy can prevent or delay transition to type 2 diabetes mellitus (T2DM) in this patient population.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

A long-term, multicentre, double-blind, randomised parallel-group trial to determine whether reducing post-prandial glycaemia can reduce cardiovascular-related morbidity and mortality in patients with established coronary heart disease or acute coronary syndrome who have impaired glucose tolerance.

Тип исследования

Интервенционный

Регистрация (Действительный)

6526

Фаза

  • Фаза 4

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Гонконг
      • Hong Kong, Гонконг
        • Prince of Wales Hospital
  • Китай
    • Anhui
      • Hefei, Anhui, Китай, 230032
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, Китай, 100034
        • Peking University First Hospital
      • Beijing, Beijing, Китай, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing, Китай, 100053
        • Xuanwu Hospital Capital Medical University
      • Beijing, Beijing, Китай, 100044
        • Peking University People's Hospital
      • Beijing, Beijing, Китай, 100853
        • PLA General Hospital
      • Beijing, Beijing, Китай, 100029
        • China-Japan Friendship Hospital
      • Beijing, Beijing, Китай, 100028
        • China Meitan General Hospital
      • Beijing, Beijing, Китай, 100038
        • Beijing Shijitan Hospital
      • Beijing, Beijing, Китай, 100038
        • Fu Xing Hospital
      • Beijing, Beijing, Китай, 100035
        • Beijing Ji Shui Tan Hospital
      • Beijing, Beijing, Китай, 100022
        • Beijing Chuiyangliu Hospital
      • Beijing, Beijing, Китай, 100029
        • Beijing Anzhen Hospital of the Capital University of Medical Sciences
      • Beijing, Beijing, Китай, 100043
        • Beijing Shijingshan Hospital
      • Beijing, Beijing, Китай, 100049
        • Aerospace Central Hospital
      • Beijing, Beijing, Китай, 100050
        • Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital
      • Beijing, Beijing, Китай, 100053
        • Wangjing Hospital of CACMS
      • Beijing, Beijing, Китай, 100054
        • Beijing Healthy Palace Hospital
      • Beijing, Beijing, Китай, 100074
        • Aerospace 731 Hospital
      • Beijing, Beijing, Китай, 100088
        • General Hospital of Second Artillery PLA
      • Beijing, Beijing, Китай, 101200
        • Anzhen Hospital of The Capital University of Medical Sciences 2nd.
      • Beijing, Beijing, Китай, 101200
        • Beijing Pinggu Hospital
      • Beijing, Beijing, Китай, 102500
        • Beijing Yanhua Hospital
    • Chongqing
      • Chongqing, Chongqing, Китай, 400016
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, Китай, 400010
        • Chongqing Medical University Second Afflicated Hospital
      • Chongqing, Chongqing, Китай, 400013
        • Chongqing Zhongshan Hospital
      • Chongqing, Chongqing, Китай, 400014
        • Chongqing Third People's Hospital
      • Chongqing, Chongqing, Китай, 400042
        • Da Ping Hospital
      • Chongqing, Chongqing, Китай, 402160
        • The Second People's Hospital of Chongqing
    • Fujian
      • Fuzhou, Fujian, Китай, 350001
        • Fujian Provincial Hospital
      • Fuzhou, Fujian, Китай, 350001
        • Union Hospital Affiliated to Fujian Medical University
      • Fuzhou, Fujian, Китай, 350004
        • The People's Hospital of Fujian Province
      • Xiamen, Fujian, Китай, 361004
        • Zhongshan Hospital Xiamen University
      • Xiamen, Fujian, Китай, 361003
        • The First Hospital of Xiamen
    • Guangdong
      • Guangzhou, Guangdong, Китай, 510080
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, Китай, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, Китай, 510080
        • Guangdong General Hospital
      • Guangzhou, Guangdong, Китай, 510630
        • The first affiliated hospital of Jinan University
      • Guangzhou, Guangdong, Китай, 510150
        • The Third Affiliated Hospital of Guangzhou Medical College
      • Guangzhou, Guangdong, Китай, 510080
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Guangzhou, Guangdong, Китай, 510507
        • Wu Jing Zhong Dui Hospital of Guangdong Province
      • Shenzhen, Guangdong, Китай, 518036
        • Peking University Shenzhen Hospital
      • Zhongshan, Guangdong, Китай, 528403
        • Zhong Shan City People's Hospital
      • Zhuhai, Guangdong, Китай, 519000
        • The Fifth Affiliated Hospital of Sun Yat-sen University
    • Guangxi
      • Liuzhou, Guangxi, Китай, 545005
        • Liuzhou Worker's Hospital
      • Liuzhou, Guangxi, Китай, 545006
        • Liuzhou People's Hospital
      • Nanning, Guangxi, Китай, 530021
        • The First Affiliated Hospital of Guangxi Medical University
      • Nanning, Guangxi, Китай, 530001
        • Minzu Hospital of Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi, Китай, 530021
        • 303 Hospital of People's Liberation Army
    • Guizhou
      • Guiyang, Guizhou, Китай, 550004
        • The affiliated Hospital of Guiyang Medical College
    • Hebei
      • Cangzhou, Hebei, Китай, 062650
        • Cangzhou Central Hospital
      • Shijiazhuang, Hebei, Китай, 050000
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, Китай, 050031
        • The First Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, Китай, 050082
        • Bethune International Peace Hospital
      • Tangshan, Hebei, Китай, 063000
        • Tangshan Workers Hospital
      • Tangshan, Hebei, Китай, 063000
        • The Affiliated Hospital of North China Coal Medical University
      • Tangshan, Hebei, Китай, 064100
        • Yu Tian County Hospital
      • Zhangjiakou, Hebei, Китай, 075000
        • The Third Affiliated Hospital of Hebei North University
    • Heilongjiang
      • Da Qing, Heilongjiang, Китай, 163001
        • Da Qing Oilfield General Hospital
      • Harbin, Heilongjiang, Китай, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang, Henan, Китай, 471003
        • The First Affiliated Hospital of Henan Science ＆ Technology University
      • Luoyang, Henan, Китай, 471009
        • Luo Yang Central Hospital, Affiliated to Zhengzhou University
      • ZhengZhou, Henan, Китай, 450014
        • The Second Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, Китай, 450000
        • The First Affiliated Hospital of Henan College of TCM
      • Zhengzhou, Henan, Китай, 450003
        • The People's Hospital of Zhengzhou
    • Hubei
      • Wuhan, Hubei, Китай, 430071
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, Китай, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, Китай, 430022
        • Wuhan Asia Heart Hospital
      • Wuhan, Hubei, Китай, 430022
        • Union Hospital of Tongji Medical College of Huazhong
      • Wuhan, Hubei, Китай, 430030
        • Tongji Hospital of Tongji Medical College of Huazhong
      • Wuhan, Hubei, Китай, 430033
        • Pu'ai Hospital of Wuhan City
    • Hunan
      • Changsha, Hunan, Китай, 410008
        • Xiangya Hospital Central-South University
      • Changsha, Hunan, Китай, 410015
        • The Third Hospital of Changsha
      • Changsha, Hunan, Китай, 410005
        • Hunan Provincial People's Hospital
      • Changsha, Hunan, Китай, 410006
        • The Fourth Hospital of Changsha
    • Inner Mongolia
      • Baotou, Inner Mongolia, Китай, 014010
        • The First Affiliated Hospital of Baotou Medical College
      • Baotou, Inner Mongolia, Китай, 014040
        • Baotou Central Hospital
      • Chifeng, Inner Mongolia, Китай, 024000
        • Chifeng Municipal Hospital
      • Hohhot, Inner Mongolia, Китай, 010017
        • Inner Mongolia Hospital
    • Jiangsu
      • NanJing, Jiangsu, Китай, 210002
        • 81st Hospital of Chinese PLA
      • NanJing, Jiangsu, Китай, 210024
        • Jiangsu Province Official Hospital
      • NanJing, Jiangsu, Китай, 210029
        • Jiangsu Provincial Hospital of TCM
      • Nanjing, Jiangsu, Китай, 210008
        • Nanjing Drum Tower Hospital
      • Nanjing, Jiangsu, Китай, 210029
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, Китай, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, Китай, 211100
        • Nanjing Jiangning Hospital
      • Nanjing, Jiangsu, Китай, 210009
        • Nanjing Zhongda Hospital
      • Nanjing, Jiangsu, Китай, 210017
        • BenQ Hospital
      • Suzhou, Jiangsu, Китай, 215000
        • Suzhou Municipal Hospital
      • Wuxi, Jiangsu, Китай, 214023
        • Wuxi People's Hospital
      • Wuxi, Jiangsu, Китай, 214002
        • Wuxi No.2 People's Hospital
      • Wuxi, Jiangsu, Китай, 214041
        • Wuxi No.3 People's Hospital
      • Xuzhou, Jiangsu, Китай, 221000
        • Hospital Affiliated Xuzhou Medical University
      • Xuzhou, Jiangsu, Китай, 221006
        • The Second Affiliated Hospital of Xuzhou Medical University
      • Zhenjiang, Jiangsu, Китай, 212002
        • Zhenjiang First People's Hospital
    • Jiangxi
      • Jiujiang, Jiangxi, Китай, 332000
        • Jiujiang University Hospital
      • Nanchang, Jiangxi, Китай, 330006
        • The Second Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, Китай, 330006
        • Jiangxi Provincial People's Hospital
      • Nanchang, Jiangxi, Китай, 330008
        • The Third Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, Китай, 130033
        • China-Japan Union Hospital of Jilin University
      • Changchun, Jilin, Китай, 130041
        • The Second Hospital of Jilin University
    • Liaoning
      • Anshan, Liaoning, Китай, 114001
        • The Central Hospital of Anshan
      • Dalian, Liaoning, Китай, 116011
        • The First Hospital of Dalian Medical University
      • Dalian, Liaoning, Китай, 116001
        • Affiliated Zhongshan Hospital Of dalian University
      • Dalian, Liaoning, Китай, 116033
        • Dalian Central Hospital
      • Shengyang, Liaoning, Китай, 712000
        • Xianyang Central Hospital
      • Shenyang, Liaoning, Китай, 110016
        • The People's Hospital of Liaoning Province
      • Shenyang, Liaoning, Китай, 110004
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, Китай, 110021
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, Китай, 110032
        • The Fourth Hospital of China Medical University
    • Ningxia
      • Yinchuan, Ningxia, Китай, 750004
        • Affiliated Hospital of Ningxia Medical University
      • Yinchuan, Ningxia, Китай, 750001
        • The First Hospital of Yinchuan
      • Yinchuan, Ningxia, Китай, 750021
        • The People's Hospital of Ningxia Hui Autonomous Region
    • Shaanxi
      • Xi'an, Shaanxi, Китай, 710061
        • The first Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, Китай, 710003
        • Xi'an Central Hospital
      • Xi'an, Shaanxi, Китай, 710077
        • Affiliated Hospital of Xi'an Medical college
      • Yan'an, Shaanxi, Китай, 716000
        • Affiliated Hospital of Yan'an University
      • Yanan, Shaanxi, Китай, 716000
        • Yan'an People's Hospital
      • Yulin, Shaanxi, Китай, 719000
        • The first hospital of yulin
    • Shandong
      • Jinan, Shandong, Китай, 250013
        • The Central Hospital of Jinan
      • Jinan, Shandong, Китай, 250013
        • The First People's Hospital of Jinan
      • Jinan, Shandong, Китай, 250031
        • The General Hospital of Jinan Military Region
      • Linyi, Shandong, Китай, 276003
        • Linyi People's Hospital
      • Qingdao, Shandong, Китай, 266003
        • Hospital Affiliated of Medical School, Qingdao University
      • Qingdao, Shandong, Китай, 266011
        • The Qingdao Municiple Hospital
      • Shibei, Shandong, Китай, 266034
        • Qingdao Fuwai Hospital
      • Taian, Shandong, Китай, 271000
        • Taian City Central Hospital
    • Shanghai
      • Shanghai, Shanghai, Китай, 200433
        • Changhai Hospital
      • Shanghai, Shanghai, Китай, 200120
        • Shanghai East Hospital
      • Shanghai, Shanghai, Китай, 200011
        • Shanghai Ninth People's Hospital
      • Shanghai, Shanghai, Китай, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, Китай, 200072
        • Shanghai Tenth People's Hospital
      • Shanghai, Shanghai, Китай, 200032
        • Shanghai Zhongshan Hospital
      • Shanghai, Shanghai, Китай, 200065
        • Tongji Hospital of Tongji University
      • Shanghai, Shanghai, Китай, 200135
        • Shanghai Pudong New Area Gongli Hospital
      • Shanghai, Shanghai, Китай, 200025
        • Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School
      • Shanghai, Shanghai, Китай, 200031
        • Shanghai Central Hospital of Xuhui District
      • Shanghai, Shanghai, Китай, 200040
        • ShangHai Huadong Hospital
      • Shanghai, Shanghai, Китай, 200060
        • Shanghai Putuo District People's Hospital
      • Shanghai, Shanghai, Китай, 200062
        • Putuo District Center Hospital
      • Shanghai, Shanghai, Китай, 200081
        • Number 411 Hospital of PLA
      • Shanghai, Shanghai, Китай, 200090
        • Shanghai Central Hospital of Yangpu District
      • Shanghai, Shanghai, Китай, 200127
        • Renji Hospital Affilicated to Jiaotong University School of Medicine
      • Shanghai, Shanghai, Китай, 200435
        • Shanghai Zhabei District Shibei Hospital
      • Shanghai, Shanghai, Китай, 200540
        • Shanghai Jinshan Hospital
      • Shanghai, Shanghai, Китай, 201200
        • Shanghai Pudong New District People's Hospital
    • Shanxi
      • Taiyuan, Shanxi, Китай, 030024
        • Shanxi Cardiovascular Hospital
      • Taiyuan, Shanxi, Китай, 030003
        • General Hospital of TISCO
      • Taiyuan, Shanxi, Китай, 030006
        • The Third Engineering Bureau Hospital of Ministry of Railway
      • Taiyuan, Shanxi, Китай, 030009
        • Taiyuan City Central Hospital
      • Xi'an, Shanxi, Китай, 710054
        • PLA No.323 Hospital
    • Sichuan
      • Chengdu, Sichuan, Китай, 610017
        • Chengdu Second People's Hospital
      • Chengdu, Sichuan, Китай, 610016
        • Chengdu First People's Hospital
      • Chengdu, Sichuan, Китай, 610041
        • Sichuan Provincial People's Hospital
      • Chengdu, Sichuan, Китай, 610041
        • The West China Hospital
      • Sichuan, Sichuan, Китай, 621000
        • Sichuan Mianyang 404 Hospital
    • Tianjin
      • Tianjin, Tianjin, Китай, 300051
        • Tianjin Chest Hospital
      • Tianjin, Tianjin, Китай, 300170
        • Tianjin Third Central Hospital
      • Tianjin, Tianjin, Китай, 300211
        • The Second Hospital of Tianjin Medical University
      • Tianjin, Tianjin, Китай, 300192
        • Tianjin First Center Hospital
      • Tianjin, Tianjin, Китай, 300050
        • Tianjin Union Hospital
      • Tianjin, Tianjin, Китай, 300121
        • Tianjin Union Medicine Centre
      • Tianjin, Tianjin, Китай, 300162
        • Army Police's Medical College Affiliated Hospital
      • Tianjin, Tianjin, Китай, 300280
        • Dagang Oil-Field General Hospital
      • Tianjin, Tianjin, Китай, 300450
        • The Fifth Central Hospital of Tianjin
    • Xinjiang
      • Shihezi, Xinjiang, Китай, 832008
        • First Affiliated Hospital of the Medical College
      • Urumqi, Xinjiang, Китай, 830054
        • The First Teaching Hospital of Xinjiang Medical University
      • Urumqi, Xinjiang, Китай, 830000
        • Xin Jiang Traditional Chinese Medicine Hospital
      • Urumqi, Xinjiang, Китай, 830002
        • General Hospital of Xinjiang Production and Construction Corps
      • Urumqi, Xinjiang, Китай, 830013
        • The 474th Hospital of PLA
    • Yunnan
      • Kunming, Yunnan, Китай, 650032
        • The First Affiliated Hospital of Kunming Medical College
      • Kunming, Yunnan, Китай, 650032
        • The First People's Hospital of Yunnan Province
      • Kunming, Yunnan, Китай, 650101
        • The Second Affiliated Hospital of Kunming Medical College
      • Yuxi, Yunnan, Китай, 653100
        • People's Hospital of Yuxi City
    • Zhejiang
      • Hangzhou, Zhejiang, Китай, 310013
        • Zhe Jiang Hospital
      • Hangzhou, Zhejiang, Китай, 310016
        • Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhe Jiang University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

50 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Male or female, aged 50 years or more.

  • Definite CHD, defined as a, b or c below:

    1. Previous myocardial infarction (MI) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following:

      • Typical clinical presentation
      • Confirmatory ECG changes
      • Appropriate elevation of cardiac enzymes/biomarkers

    2. Previous unstable angina (UA) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following:

      • Typical clinical presentation
      • Confirmatory ECG changes
      • Either elevation of a cardiac biomarker or a >50% stenosis in ≥1 major epicardial coronary artery shown on coronary angiography or CT angiography. Where stenosis is reported in a qualitative manner, the categories "moderate" and "severe" will be taken as equating to >50% stenosis.

    3. Current stable angina defined as:

      • Typical clinical history with symptoms occurring within the last month, and
      • A >50% stenosis in ≥1 major epicardial coronary artery shown on coronary angiography or CT angiography. Where stenosis is reported in a qualitative manner, the categories "moderate" and "severe" will be taken as equating to >50% stenosis.
  • Impaired glucose tolerance diagnosed on a single standard oral glucose tolerance test (OGTT) , defined as a 2-hour plasma glucose (2HPG) value ≥7.8 but <11.1 mmol/l and a fasting plasma glucose (FPG) <7.0 mmol/l within six months prior to enrollment.
  • Optimised cardiovascular drug therapy.
  • At least 80% adherent to single blind placebo Study Medication during the run-in period.
  • Provision of written informed consent.

Exclusion Criteria:

  • Previous history of diabetes, other than gestational diabetes.
  • MI, unstable angina, stroke or a transient ischaemic attack (TIA) within the previous three months.
  • Planned or anticipated coronary, cerebrovascular or peripheral arterial revascularisation or other major surgical intervention, at the time of randomisation
  • New York Heart Association (NYHA) class III or IV heart failure.
  • Evidence of severe hepatic disease.
  • Evidence of severe renal impairment or an eGFR <30 ml/min/1.73m2 (derived using the Modification of Diet in Renal Disease, MDRD, Chinese equation)
  • Any other condition likely to reduce adherence to the protocol e.g. alcoholism, major active psychiatric disorder, cognitive impairment or a condition likely to markedly limit life expectancy e.g. malignancy.
  • Pregnancy (or planned pregnancy within the next five years).
  • Concurrent participation in any other clinical interventional trial. Note: Patients who were treated previously with an alphaglucosidase inhibitor must have at least a three-month washout period before being randomised into the ACE trial.
  • Known intolerance to alpha glucosidase inhibitors or gastrointestinal problems.
  • Thought by the investigator for any reason to be unsuitable for participation in this clinical study.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Acarbose
The participants were given one tablet (50mg) of acarbose per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day (50mg twice a day i.e. 100mg/day) and then three tablets/day (50mg three times a day i.e. 150mg/day) thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 150mg/day).
Лекарство: Acarbose
The participants were given one tablet (50mg) of acarbose per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day (50mg twice a day i.e. 100mg/day) and then three tablets/day (50mg three times a day i.e. 150mg/day) thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 150mg/day).
Другие имена:
  • Глюкобай
Плацебо Компаратор: Matching Placebo
The participants were given one tablet of matching placebo per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 3 tablets/day).
Лекарство: Matching Placebo
The participants were given one tablet of matching placebo per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 3 tablets/day).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Временное ограничение
A composite cardiovascular outcome defined as the time after randomisation to the first occurrence of any one of the following: -Cardiovascular death -Non-fatal MI -Non-fatal stroke -Hospitalisation for Unstable Angina -Hospitalisation for Heart Failure
Временное ограничение: Follow-up until 728 adjudicated Primary Outcome Measures have been recorded
Follow-up until 728 adjudicated Primary Outcome Measures have been recorded

Вторичные показатели результатов

Мера результата
Все вызывают смертность
Transition to type 2 diabetes confirmed by two successive diagnostic plasma glucose values (FPG >7.0 mmol/l and/or 2HPG > 11.1 mmol/l), with no intervening non-diagnostic values.
Each of the components of the primary composite cardiovascular outcome will also be analysed individually, both as first and as total events.
Major Cardiovascular Event (MACE) composite cardiovascular outcome, defined as the time after randomisation to the first occurrence of any one of the following: - Cardiovascular death - Non-fatal MI - Non-fatal stroke
Impaired renal function as evidenced by: A reduced estimate of glomerular filtration rate( eGFR <30 ml/minute/ 1.73 m2) estimated using the Chinese MDRD formula, a doubling of the baseline plasma creatinine level, a halving of the baseline eGFR
Resource use, costs and cost effectiveness

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Oxford

Соавторы

Bayer

Следователи

  • Главный следователь: Professor Rury R Holman, FRCP FMedSci, Diabetes Trials Unit, University of Oxford

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

17 февраля 2009 г.

Первичное завершение (Действительный)

11 апреля 2017 г.

Завершение исследования (Действительный)

18 апреля 2017 г.

Даты регистрации исследования

Первый отправленный

26 января 2009 г.

Впервые представлено, что соответствует критериям контроля качества

26 января 2009 г.

Первый опубликованный (Оценивать)

27 января 2009 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 июля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 июля 2017 г.

Последняя проверка

1 июля 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 11232
  • ISRCTN91899513

Планирование данных отдельных участников (IPD)

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НЕ РЕШЕНО

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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