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Acarbose Cardiovascular Evaluation Trial (ACE)

21. července 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

6526

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

50 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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).
Lék: 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).
Ostatní jména:
  • Glucobay
Komparátor placeba: 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).
Lék: 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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
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
Časové okno: Follow-up until 728 adjudicated Primary Outcome Measures have been recorded
Follow-up until 728 adjudicated Primary Outcome Measures have been recorded

Sekundární výstupní opatření

Měření výsledku
Všechny způsobují úmrtnost
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Oxford

Spolupracovníci

Bayer

Vyšetřovatelé

  • Vrchní vyšetřovatel: Professor Rury R Holman, FRCP FMedSci, Diabetes Trials Unit, University of Oxford

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. února 2009

Primární dokončení (Aktuální)

11. dubna 2017

Dokončení studie (Aktuální)

18. dubna 2017

Termíny zápisu do studia

První předloženo

26. ledna 2009

První předloženo, které splnilo kritéria kontroly kvality

26. ledna 2009

První zveřejněno (Odhad)

27. ledna 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

25. července 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. července 2017

Naposledy ověřeno

1. července 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 11232
  • ISRCTN91899513

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

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