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Acarbose Cardiovascular Evaluation Trial (ACE)

21 lipca 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

6526

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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).
Lek: 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).
Inne nazwy:
  • Glucobay
Komparator placebo: 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).
Lek: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
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
Ramy czasowe: Follow-up until 728 adjudicated Primary Outcome Measures have been recorded
Follow-up until 728 adjudicated Primary Outcome Measures have been recorded

Miary wyników drugorzędnych

Miara wyniku
Wszystkie powodują śmiertelność
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Oxford

Współpracownicy

Bayer

Śledczy

  • Główny śledczy: Professor Rury R Holman, FRCP FMedSci, Diabetes Trials Unit, University of Oxford

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 lutego 2009

Zakończenie podstawowe (Rzeczywisty)

11 kwietnia 2017

Ukończenie studiów (Rzeczywisty)

18 kwietnia 2017

Daty rejestracji na studia

Pierwszy przesłany

26 stycznia 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 stycznia 2009

Pierwszy wysłany (Oszacować)

27 stycznia 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 lipca 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 lipca 2017

Ostatnia weryfikacja

1 lipca 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 11232
  • ISRCTN91899513

Plan dla danych uczestnika indywidualnego (IPD)

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