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Acarbose Cardiovascular Evaluation Trial (ACE)

21 luglio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

6526

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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).
Droga: 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).
Altri nomi:
  • Glucobay
Comparatore 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).
Droga: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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
Lasso di tempo: Follow-up until 728 adjudicated Primary Outcome Measures have been recorded
Follow-up until 728 adjudicated Primary Outcome Measures have been recorded

Misure di risultato secondarie

Misura del risultato
Tutti causano mortalità
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Oxford

Collaboratori

Bayer

Investigatori

  • Investigatore principale: Professor Rury R Holman, FRCP FMedSci, Diabetes Trials Unit, University of Oxford

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 febbraio 2009

Completamento primario (Effettivo)

11 aprile 2017

Completamento dello studio (Effettivo)

18 aprile 2017

Date di iscrizione allo studio

Primo inviato

26 gennaio 2009

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2009

Primo Inserito (Stima)

27 gennaio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 luglio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2017

Ultimo verificato

1 luglio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 11232
  • ISRCTN91899513

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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