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Acarbose Cardiovascular Evaluation Trial (ACE)

Primary Purpose

Coronary Heart Disease, Acute Coronary Syndrome, Impaired Glucose Tolerance

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Acarbose
Matching Placebo
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease focused on measuring Acarbose

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical University
  • Beijing Chuiyangliu Hospital
  • China Meitan General Hospital
  • Beijing Anzhen Hospital of The Capital University of Medical Sciences
  • China-Japan Friendship Hospital
  • Peking University First Hospital
  • Beijing Ji Shui Tan Hospital
  • Beijing Shijitan Hospital
  • Fu Xing Hospital
  • Beijing Shijingshan Hospital
  • Peking University People's Hospital
  • Aerospace Central Hospital
  • Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital
  • Wangjing Hospital of CACMS
  • Xuanwu Hospital Capital Medical University
  • Beijing Healthy Palace Hospital
  • Aerospace 731 Hospital
  • General Hospital of Second Artillery PLA
  • Peking Union Medical College Hospital
  • PLA General Hospital
  • Anzhen Hospital of The Capital University of Medical Sciences 2nd.
  • Beijing Pinggu Hospital
  • Beijing Yanhua Hospital
  • Chongqing Medical University Second Afflicated Hospital
  • Chongqing Zhongshan Hospital
  • Chongqing Third People's Hospital
  • The First Affiliated Hospital of Chongqing Medical University
  • Da Ping Hospital
  • The Second People's Hospital of Chongqing
  • Fujian Provincial Hospital
  • Union Hospital Affiliated to Fujian Medical University
  • The People's Hospital of Fujian Province
  • The First Hospital of Xiamen
  • Zhongshan Hospital Xiamen University
  • Guangdong General Hospital
  • The First Affiliated Hospital of Guangdong Pharmaceutical University
  • The First Affiliated Hospital of Sun Yat-Sen University
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • The Third Affiliated Hospital of Guangzhou Medical College
  • Wu Jing Zhong Dui Hospital of Guangdong Province
  • The First Affiliated Hospital of Jinan University
  • Peking University Shenzhen Hospital
  • Zhong Shan City People's Hospital
  • The Fifth Affiliated Hospital of Sun Yat-Sen University
  • Liuzhou Worker's Hospital
  • Liuzhou People's Hospital
  • Minzu Hospital of Guangxi Zhuang Autonomous Region
  • 303 Hospital of People's Liberation Army
  • The First Affiliated Hospital of Guangxi Medical University
  • The Affiliated Hospital of Guiyang Medical College
  • Cangzhou Central Hospital
  • The Second Hospital of Hebei Medical University
  • The First Hospital of Hebei Medical University
  • Bethune International Peace Hospital
  • Tangshan Workers Hospital
  • The Affiliated Hospital of North China Coal Medical University
  • Yu Tian County Hospital
  • The Third Affiliated Hospital of Hebei North University
  • Da Qing Oilfield General Hospital
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The First Affiliated Hospital of Henan Science & Technology University
  • Luo Yang Central Hospital, Affiliated to Zhengzhou University
  • The First Affiliated Hospital of Henan College of TCM
  • The People's Hospital of Zhengzhou
  • The Second Affiliated Hospital of Zhengzhou University
  • Union Hospital of Tongji Medical College of Huazhong
  • Wuhan Asia Heart Hospital
  • Tongji Hospital of Tongji Medical College of Huazhong
  • Pu'ai Hospital of Wuhan City
  • Renmin Hospital of Wuhan University
  • Zhongnan Hospital of Wuhan University
  • Hunan Provincial People's Hospital
  • The Fourth Hospital of Changsha
  • Xiangya Hospital Central-South University
  • The Third Hospital of Changsha
  • The First Affiliated Hospital of Baotou Medical College
  • Baotou Central Hospital
  • Chifeng Municipal Hospital
  • Inner Mongolia Hospital
  • 81st Hospital of Chinese PLA
  • Nanjing First Hospital
  • Nanjing Drum Tower Hospital
  • Nanjing Zhongda Hospital
  • BENQ Hospital
  • Jiangsu Province Official Hospital
  • Jiangsu Province Hospital
  • Jiangsu Provincial Hospital of TCM
  • Nanjing Jiangning Hospital
  • Suzhou Municipal Hospital
  • Wuxi No.2 People's Hospital
  • Wuxi People's Hospital
  • Wuxi No.3 People's Hospital
  • Hospital Affiliated Xuzhou Medical University
  • The Second Affiliated Hospital of Xuzhou Medical University
  • Zhenjiang First People's Hospital
  • Jiujiang University Hospital
  • Jiangxi Provincial People's Hospital
  • The Second Affiliated Hospital of Nanchang University
  • The Third Affiliated Hospital of Nanchang University
  • China-Japan Union Hospital of Jilin University
  • The Second Hospital of Jilin University
  • The Central Hospital of Anshan
  • Affiliated Zhongshan Hospital of Dalian University
  • The First Hospital of Dalian Medical University
  • Dalian Central Hospital
  • Xianyang Central Hospital
  • Shengjing Hospital of China Medical University
  • The People's Hospital of Liaoning Province
  • Shengjing Hospital of China Medical University
  • The Fourth Hospital of China Medical University
  • The First Hospital of Yinchuan
  • Affiliated Hospital of Ningxia Medical University
  • The People's Hospital of Ningxia Hui Autonomous Region
  • Xi'an Central Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Affiliated Hospital of Xi'an Medical college
  • Affiliated Hospital of Yan'an University
  • Yan'an People's Hospital
  • The First Hospital of Yulin
  • The Central Hospital of Jinan
  • The First People's Hospital of Jinan
  • The General Hospital of Jinan Military Region
  • Linyi People's Hospital
  • Hospital Affiliated of Medical School, Qingdao University
  • The Qingdao Municiple Hospital
  • Qingdao Fuwai Hospital
  • Taian City Central Hospital
  • Shanghai Ninth People's Hospital
  • Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School
  • Shanghai Central Hospital of Xuhui District
  • Shanghai Zhongshan Hospital
  • Shanghai Huadong Hospital
  • Shanghai Putuo District People's Hospital
  • Putuo District Center Hospital
  • Tongji Hospital of Tongji University
  • Shanghai Tenth People's Hospital
  • Number 411 Hospital of PLA
  • Shanghai Central Hospital of Yangpu District
  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Shanghai East Hospital
  • Renji Hospital Affilicated to Jiaotong University School of Medicine
  • Shanghai Pudong New Area Gongli Hospital
  • Changhai Hospital
  • Shanghai Zhabei District Shibei Hospital
  • Shanghai Jinshan Hospital
  • Shanghai Pudong New District People's Hospital
  • General Hospital of Tisco
  • The Third Engineering Bureau Hospital of Ministry of Railway
  • Taiyuan City Central Hospital
  • Shanxi Cardiovascular Hospital
  • PLA No.323 Hospital
  • Chengdu First People's Hospital
  • Chengdu Second People's Hospital
  • Sichuan Provincial People's Hospital
  • The West China Hospital
  • Sichuan Mianyang 404 Hospital
  • Tianjin Union Hospital
  • Tianjin Chest Hospital
  • Tianjin Union Medicine Centre
  • Army Police's Medical College Affiliated Hospital
  • Tianjin Third Central Hospital
  • Tianjin First Center Hospital
  • The Second Hospital of Tianjin Medical University
  • Dagang Oil-Field General Hospital
  • The Fifth Central Hospital of Tianjin
  • First Affiliated Hospital of the Medical College
  • Xin Jiang Traditional Chinese Medicine Hospital
  • General Hospital of Xinjiang Production and Construction Corps
  • The 474th Hospital of PLA
  • The First Teaching Hospital of Xinjiang Medical University
  • The First Affiliated Hospital of Kunming Medical College
  • The First People's Hospital of Yunnan Province
  • The Second Affiliated Hospital of Kunming Medical College
  • People's Hospital of Yuxi City
  • Zhe Jiang Hospital
  • Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhe Jiang University
  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acarbose

Matching Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
All cause mortality
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

Full Information

First Posted
January 26, 2009
Last Updated
July 21, 2017
Sponsor
University of Oxford
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00829660
Brief Title
Acarbose Cardiovascular Evaluation Trial
Acronym
ACE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 17, 2009 (Actual)
Primary Completion Date
April 11, 2017 (Actual)
Study Completion Date
April 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Acute Coronary Syndrome, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus (T2DM)
Keywords
Acarbose

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acarbose
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Acarbose
Other Intervention Name(s)
Glucobay
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Time Frame
Follow-up until 728 adjudicated Primary Outcome Measures have been recorded
Secondary Outcome Measure Information:
Title
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.
Title
All cause mortality
Title
Each of the components of the primary composite cardiovascular outcome will also be analysed individually, both as first and as total events.
Title
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
Title
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
Title
Resource use, costs and cost effectiveness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged 50 years or more. Definite CHD, defined as a, b or c below: 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 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Rury R Holman, FRCP FMedSci
Organizational Affiliation
Diabetes Trials Unit, University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China
Facility Name
Beijing Chuiyangliu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100022
Country
China
Facility Name
China Meitan General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100028
Country
China
Facility Name
Beijing Anzhen Hospital of The Capital University of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Ji Shui Tan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Facility Name
Fu Xing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Facility Name
Beijing Shijingshan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100043
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Aerospace Central Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100049
Country
China
Facility Name
Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Wangjing Hospital of CACMS
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Beijing Healthy Palace Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100054
Country
China
Facility Name
Aerospace 731 Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100074
Country
China
Facility Name
General Hospital of Second Artillery PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Anzhen Hospital of The Capital University of Medical Sciences 2nd.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101200
Country
China
Facility Name
Beijing Pinggu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101200
Country
China
Facility Name
Beijing Yanhua Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102500
Country
China
Facility Name
Chongqing Medical University Second Afflicated Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Chongqing Zhongshan Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400013
Country
China
Facility Name
Chongqing Third People's Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Da Ping Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
The Second People's Hospital of Chongqing
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
402160
Country
China
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Union Hospital Affiliated to Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
The People's Hospital of Fujian Province
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China
Facility Name
The First Hospital of Xiamen
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Guangdong Pharmaceutical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The Third Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510150
Country
China
Facility Name
Wu Jing Zhong Dui Hospital of Guangdong Province
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510507
Country
China
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Facility Name
Zhong Shan City People's Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528403
Country
China
Facility Name
The Fifth Affiliated Hospital of Sun Yat-Sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Facility Name
Liuzhou Worker's Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545005
Country
China
Facility Name
Liuzhou People's Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545006
Country
China
Facility Name
Minzu Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530001
Country
China
Facility Name
303 Hospital of People's Liberation Army
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
The Affiliated Hospital of Guiyang Medical College
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Facility Name
Cangzhou Central Hospital
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
062650
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China
Facility Name
Bethune International Peace Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050082
Country
China
Facility Name
Tangshan Workers Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
The Affiliated Hospital of North China Coal Medical University
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
Yu Tian County Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
064100
Country
China
Facility Name
The Third Affiliated Hospital of Hebei North University
City
Zhangjiakou
State/Province
Hebei
ZIP/Postal Code
075000
Country
China
Facility Name
Da Qing Oilfield General Hospital
City
Da Qing
State/Province
Heilongjiang
ZIP/Postal Code
163001
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Henan Science & Technology University
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
Luo Yang Central Hospital, Affiliated to Zhengzhou University
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471009
Country
China
Facility Name
The First Affiliated Hospital of Henan College of TCM
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
The People's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
ZhengZhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Facility Name
Union Hospital of Tongji Medical College of Huazhong
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Pu'ai Hospital of Wuhan City
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430033
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
The Fourth Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Xiangya Hospital Central-South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Third Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410015
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014040
Country
China
Facility Name
Chifeng Municipal Hospital
City
Chifeng
State/Province
Inner Mongolia
ZIP/Postal Code
024000
Country
China
Facility Name
Inner Mongolia Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010017
Country
China
Facility Name
81st Hospital of Chinese PLA
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Nanjing Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
BENQ Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210017
Country
China
Facility Name
Jiangsu Province Official Hospital
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
210024
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Jiangsu Provincial Hospital of TCM
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Nanjing Jiangning Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211100
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214002
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Wuxi No.3 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214041
Country
China
Facility Name
Hospital Affiliated Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
The Second Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Facility Name
Zhenjiang First People's Hospital
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212002
Country
China
Facility Name
Jiujiang University Hospital
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Third Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
The Central Hospital of Anshan
City
Anshan
State/Province
Liaoning
ZIP/Postal Code
114001
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
The First Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
Dalian Central Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116033
Country
China
Facility Name
Xianyang Central Hospital
City
Shengyang
State/Province
Liaoning
ZIP/Postal Code
712000
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
The People's Hospital of Liaoning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110021
Country
China
Facility Name
The Fourth Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Facility Name
The First Hospital of Yinchuan
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750001
Country
China
Facility Name
Affiliated Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
The People's Hospital of Ningxia Hui Autonomous Region
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750021
Country
China
Facility Name
Xi'an Central Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710003
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Affiliated Hospital of Xi'an Medical college
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710077
Country
China
Facility Name
Affiliated Hospital of Yan'an University
City
Yan'an
State/Province
Shaanxi
ZIP/Postal Code
716000
Country
China
Facility Name
Yan'an People's Hospital
City
Yanan
State/Province
Shaanxi
ZIP/Postal Code
716000
Country
China
Facility Name
The First Hospital of Yulin
City
Yulin
State/Province
Shaanxi
ZIP/Postal Code
719000
Country
China
Facility Name
The Central Hospital of Jinan
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
The First People's Hospital of Jinan
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
The General Hospital of Jinan Military Region
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276003
Country
China
Facility Name
Hospital Affiliated of Medical School, Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
The Qingdao Municiple Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266011
Country
China
Facility Name
Qingdao Fuwai Hospital
City
Shibei
State/Province
Shandong
ZIP/Postal Code
266034
Country
China
Facility Name
Taian City Central Hospital
City
Taian
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Shanghai Central Hospital of Xuhui District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Huadong Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Putuo District People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200060
Country
China
Facility Name
Putuo District Center Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Tongji Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Number 411 Hospital of PLA
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200081
Country
China
Facility Name
Shanghai Central Hospital of Yangpu District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200090
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Renji Hospital Affilicated to Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Shanghai Pudong New Area Gongli Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200135
Country
China
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shanghai Zhabei District Shibei Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200435
Country
China
Facility Name
Shanghai Jinshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200540
Country
China
Facility Name
Shanghai Pudong New District People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201200
Country
China
Facility Name
General Hospital of Tisco
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030003
Country
China
Facility Name
The Third Engineering Bureau Hospital of Ministry of Railway
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030006
Country
China
Facility Name
Taiyuan City Central Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030009
Country
China
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030024
Country
China
Facility Name
PLA No.323 Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710054
Country
China
Facility Name
Chengdu First People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610016
Country
China
Facility Name
Chengdu Second People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610017
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Mianyang 404 Hospital
City
Sichuan
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Facility Name
Tianjin Union Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300050
Country
China
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300051
Country
China
Facility Name
Tianjin Union Medicine Centre
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Name
Army Police's Medical College Affiliated Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300162
Country
China
Facility Name
Tianjin Third Central Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300170
Country
China
Facility Name
Tianjin First Center Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Dagang Oil-Field General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300280
Country
China
Facility Name
The Fifth Central Hospital of Tianjin
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300450
Country
China
Facility Name
First Affiliated Hospital of the Medical College
City
Shihezi
State/Province
Xinjiang
ZIP/Postal Code
832008
Country
China
Facility Name
Xin Jiang Traditional Chinese Medicine Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
General Hospital of Xinjiang Production and Construction Corps
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830002
Country
China
Facility Name
The 474th Hospital of PLA
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830013
Country
China
Facility Name
The First Teaching Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
The First Affiliated Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
The Second Affiliated Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650101
Country
China
Facility Name
People's Hospital of Yuxi City
City
Yuxi
State/Province
Yunnan
ZIP/Postal Code
653100
Country
China
Facility Name
Zhe Jiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China
Facility Name
Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhe Jiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33035598
Citation
Wamil M, McMurray JJV, Scott CAB, Coleman RL, Sun Y, Standl E, Ryden L, Holman RR. Predicting heart failure events in patients with coronary heart disease and impaired glucose tolerance: Insights from the Acarbose Cardiovascular Evaluation (ACE) trial. Diabetes Res Clin Pract. 2020 Dec;170:108488. doi: 10.1016/j.diabres.2020.108488. Epub 2020 Oct 6.
Results Reference
derived
PubMed Identifier
32641379
Citation
Gerstein HC, Coleman RL, Scott CAB, Xu S, Tuomilehto J, Ryden L, Holman RR; ACE Study Group. Impact of Acarbose on Incident Diabetes and Regression to Normoglycemia in People With Coronary Heart Disease and Impaired Glucose Tolerance: Insights From the ACE Trial. Diabetes Care. 2020 Sep;43(9):2242-2247. doi: 10.2337/dc19-2046. Epub 2020 Jul 8.
Results Reference
derived
PubMed Identifier
28917545
Citation
Holman RR, Coleman RL, Chan JCN, Chiasson JL, Feng H, Ge J, Gerstein HC, Gray R, Huo Y, Lang Z, McMurray JJ, Ryden L, Schroder S, Sun Y, Theodorakis MJ, Tendera M, Tucker L, Tuomilehto J, Wei Y, Yang W, Wang D, Hu D, Pan C; ACE Study Group. Effects of acarbose on cardiovascular and diabetes outcomes in patients with coronary heart disease and impaired glucose tolerance (ACE): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):877-886. doi: 10.1016/S2213-8587(17)30309-1. Epub 2017 Sep 13. Erratum In: Lancet Diabetes Endocrinol. 2017 Nov;5(11):e7. Lancet Diabetes Endocrinol. 2019 May;7(5):e5.
Results Reference
derived
Links:
URL
http://www.dtu.ox.ac.uk/ACE
Description
Diabetes Trials Unit, International Co-ordinating Centre for the ACE Trial

Learn more about this trial

Acarbose Cardiovascular Evaluation Trial

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