Acarbose Cardiovascular Evaluation Trial (ACE)

This study is currently recruiting participants.
Verified September 2011 by University of Oxford
Sponsor:
Collaborator:
Bayer
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00829660
First received: January 26, 2009
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
Acute Coronary Syndrome
Impaired Glucose Tolerance
Type 2 Diabetes Mellitus (T2DM)
Drug: Acarbose
Drug: Matching Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase IV Trial to Determine Whether Reducing Post-prandial Glycaemia Can Reduce Cardiovascular-related Morbidity in Patients With Established Coronary Heart Disease or Acute Coronary Syndrome Who Have Impaired Glucose Tolerance.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Occurrence of any of the following; Cardiovascular death, Non-fatal MI, Non-fatal stroke [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transition to type 2 diabetes [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for heart failure or hospitalization for unstable angina. [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Evidence of NAFLD [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Impaired renal function [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Resource use, costs and cost effectiveness [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]

Estimated Enrollment: 7500
Study Start Date: February 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acarbose Drug: Acarbose
The participants will be given one tablet (50mg) of acarbose per day to be taken with a meal during their first week (7 days). During the second week, the dose is 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 will be taken for the duration of the trial (maximum dose is 150mg/day).
Other Name: Glucobay
Placebo Comparator: Matching Placebo Drug: Matching Placebo
The participants will be given one tablet of matching placebo per day to be taken with a meal during their first week (7 days). During the second week, the dose is increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose will be taken for the duration of the trial (maximum dose is 3 tablets/day).

Detailed Description:

A 4-year, multi-centre, double-blind, randomised parallel-group trial to determine whether reducing post-prandial glycaemia can reduce cardiovascular-related morbidity in patients with established coronary heart disease or acute coronary syndrome who have impaired glucose tolerance.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (Note: Patients with stents are eligible):

      • 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 75g anhydrous glucose 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.
  • 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 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829660

Contacts
Contact: Professor Rury R Holman, FRCP +44 (0) 1865 857240 ace@dtu.ox.ac.uk

  Hide Study Locations
Locations
China, Beijing
PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
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Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
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Fu Xing Hospital Recruiting
Beijing, Beijing, China, 100038
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Beijing Ji Shui Tan Hospital Recruiting
Beijing, Beijing, China, 100035
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Aerospace Central Hospital Recruiting
Beijing, Beijing, China, 10049
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General Hospital of Second Artillery PLA Recruiting
Beijing, Beijing, China, 100088
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Beijing Shijingshan Hospital Recruiting
Beijing, Beijing, China, 100043
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Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
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China Meitan General Hospita Recruiting
Beijing, Beijing, China, 100028
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China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China, 100029
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Beijing Pinggu Hospital Recruiting
Beijing, Beijing, China, 101200
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Beijing Yangfangdian Hospital Recruiting
Beijing, Beijing, China, 100053
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Beijing Anzhen Hospital of The Capital University of Medical Sciences Recruiting
Beijing, Beijing, China, 100029
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Beijing Healthy Palace Hospital Recruiting
Beijing, Beijing, China, 100054
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Beijing Yanhua Hospital Recruiting
Beijing, Beijing, China, 102500
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Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital Recruiting
Beijing, Beijing, China, 100050
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Anzhen Hospital of The Capital University of Medical Sciences 2nd. Recruiting
Beijing, Beijing, China, 101200
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China, Chongqing
The Second People's Hospital of Chongqing Recruiting
Chongqing, Chongqing, China, 402160
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Chongqing Zhongshan Hospital Recruiting
Chongqing, Chongqing, China, 400013
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Chongqing Third People's Hospital Recruiting
Chongqing, Chongqing, China, 400014
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Da Ping Hospital Recruiting
Chongqing, Chongqing, China, 400042
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Chongqing Medical University Second Afflicated Hospital Recruiting
Chongqing, Chongqing, China, 400010
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China, Fujian
Fujian Provincial Hospital Recruiting
Fuzhou, Fujian, China, 350001
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The People's Hospital of Fujian Province Recruiting
Fuzhou, Fujian, China, 350004
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The First Hospital of Xiamen Recruiting
Xiamen, Fujian, China, 361003
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Zhongshan Hospital Xiamen University Recruiting
Xiamen, Fujian, China, 361004
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China, Guangdong
The First Affiliated Hospital of Guangdong Pharmaceutical University Recruiting
Guangzhou, Guangdong, China, 510080
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The First Affiliated Hospital of jinan University Recruiting
Guangzhou, Guangdong, China, 510630
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The Third Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510150
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The First Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
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The Second Affiliated Hospital of Zhongshan University Recruiting
Guangzhou, Guangdong, China, 510120
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Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
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Peking University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China, 518036
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Zhong Shan City People's Hospital Recruiting
Zhongshan, Guangdong, China, 528403
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The Fifth Affiliated Hospital of Sun Yat-Sen University Recruiting
Zhuhai, Guangdong, China, 519000
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China, Guangxi
Liuzhou People's Hospital Recruiting
Liuzhou, Guangxi, China, 545006
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303 Hospital of People's Liberation Army Recruiting
Nanning, Guangxi, China, 530021
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Minzu Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China, 530001
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The First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
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China, Guizhou
The Affiliated Hospital of Guiyang Medical College Recruiting
Guiyang, Guizhou, China, 550004
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China, Hebei
The Second Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
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The First Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050031
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Bethune International Peace Hospital Recruiting
Shijiazhuang, Hebei, China, 050082
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Yu Tian County Hospital Recruiting
Tangshan, Hebei, China, 064100
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Tangshan Workers Hospital Recruiting
Tangshan, Hebei, China, 063000
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The Affiliated Hospital of North China Coal Medical University Recruiting
Tangshan, Hebei, China, 063000
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The Third Affiliated Hospital of Hebei North University Recruiting
Zhangjiakou, Hebei, China, 075000
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China, Heilongjiang
Da Qing Oilfield General Hospital Recruiting
Da Qing, Heilongjiang, China, 163001
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The Fourth Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
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China, Henan
The First Affiliated Hospital of Henan Science & Technology University Recruiting
Luoyang, Henan, China, 471003
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The Second Affiliated Hospital of Zhengzhou University Recruiting
ZhengZhou, Henan, China, 450014
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The First Affiliated Hospital of Henan College of TCM Recruiting
Zhengzhou, Henan, China, 450000
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The People's Hospital of Zhengzhou Recruiting
Zhengzhou, Henan, China, 450003
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China, Hongkong
Prince of Wales Hospital Recruiting
Hongkong, Hongkong, China
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China, Hubei
Pu'ai Hospital of Wuhan City Recruiting
Wuhan, Hubei, China, 430033
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Wuhan Asia Heart Hospital Recruiting
Wuhan, Hubei, China, 430022
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Union Hospital of Tongji Medical College of Huazhong Recruiting
Wuhan, Hubei, China, 430022
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Renmin Hospital of Wuhan Univdrsity Recruiting
Wuhan, Hubei, China, 430060
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Zhongnan Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430071
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Tongji Hospital of Tongji Medical College of Huazhong Recruiting
Wuhan,, Hubei, China, 430030,
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China, Hunan
Hunan Provincial People's Hospital Recruiting
Changsha, Hunan, China, 410005
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The Third Hospital of Changsha Recruiting
Changsha, Hunan, China, 410015
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The Fourth Hospital of Changsha Recruiting
Changsha, Hunan, China, 410006
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Xiangya Hospital Central-South University Recruiting
Changsha, Hunan, China, 410008
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China, Inner Mongolia
The First Affiliated Hospital of Baotou Medical College Recruiting
Baotou, Inner Mongolia, China, 014010
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Baotou Central Hospital Recruiting
Baotou, Inner Mongolia, China, 014040
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Inner Mongolia Hospita Recruiting
Hohhot, Inner Mongolia, China, 010017
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China, Jiangsu
81st Hospital of Chinese PLA Recruiting
NanJing, Jiangsu, China, 210002
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Jiangsu Province Official Hospital Recruiting
NanJing, Jiangsu, China, 210024
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Jiangsu Provincial Hospital of TCM Recruiting
NanJing, Jiangsu, China, 210029
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Nanjing Zhongda Hospital Recruiting
Nanjing, Jiangsu, China, 210009
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BENQ Hospital Recruiting
Nanjing, Jiangsu, China, 210017
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Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
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Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
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Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
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Nanjing Jiangning Hospital Recruiting
Nanjing,, Jiangsu, China, 211100
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Suzhou Municipal Hospital Recruiting
Suzhou, Jiangsu, China, 215000
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Wuxi People's Hospital Recruiting
Wuxi, Jiangsu, China, 214023
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Wuxi No.2 People's Hospital Recruiting
Wuxi, Jiangsu, China, 214002
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Wuxi No.3 People's Hospital Recruiting
Wuxi, Jiangsu, China, 214041
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Zhanjiang First People's Hospital Recruiting
Zhanjiang, Jiangsu, China, 212002
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China, Jiangxi
The Third Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330008
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Jiangxi Provincial People's Hospital Recruiting
Nanchang, Jiangxi, China, 330006
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The Second Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
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China, Jilin
China-Japan Union Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130033
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The Second Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130041
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China, Liaoning
The Central Hospital of Anshan Recruiting
Anshan, Liaoning, China, 114001
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Dalian Central Hospital Recruiting
Dalian, Liaoning, China, 116033
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The First Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116011
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Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110021
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Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
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The Fourth Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110032
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China, Ningxia
Affiliated Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
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The First Hospital of Yinchuan Recruiting
Yinchuan, Ningxia, China, 750001
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The People's Hospital of Ningxia Hui Autonomous Region Recruiting
Yinchuan, Ningxia, China, 750021
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China, Shaanxi
Xi'an Central Hospital Recruiting
Xi'an, Shaanxi, China, 710003
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The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
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Affiliated Hospital of Xi'an Medical college Recruiting
Xi'an, Shaanxi, China, 710077
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Affiliated Hospital of Yan'an University Recruiting
Yan'an, Shaanxi, China, 716000
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Yan'an People' Hospital Recruiting
Yanan, Shaanxi, China, 716000
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The First Hospital of Yulin Recruiting
Yulin, Shaanxi, China, 719000
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China, Shandong
The Central Hospital of Jinan Recruiting
Jinan, Shandong, China, 250013
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The First People's Hospital of Jinan Recruiting
Jinan, Shandong, China, 250013
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The General Hospital of Jinan Military Region Recruiting
Jinan, Shandong, China, 250031
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Linyi People's Hospital Recruiting
Linyi, Shandong, China, 276003
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The Qingdao Municiple Hospital Recruiting
Qingdao, Shandong, China, 266011
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Taian City Central Hospital Recruiting
Taian, Shandong, China, 271000
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China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200120
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Shanghai Central Hospital of Xuhui District Recruiting
Shanghai, Shanghai, China, 200031
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Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
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Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
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Shanghai Huadong Hospital Recruiting
Shanghai, Shanghai, China, 200040
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Shanghai Jinshan Hospital Recruiting
Shanghai, Shanghai, China, 200540
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Shanghai Central Hospital of Yangpu District Recruiting
Shanghai, Shanghai, China, 200090
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Number 411 Hospital of PLA Recruiting
Shanghai, Shanghai, China, 200081
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Shanghai Pudong New District People's Hospital Recruiting
Shanghai, Shanghai, China, 201200
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Shanghai Putuo District People's Hospital Recruiting
Shanghai, Shanghai, China, 200060
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Shanghai Ninth People's Hospital Recruiting
Shanghai, Shanghai, China, 200011
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Putuo District Center Hospital Recruiting
Shanghai, Shanghai, China, 200062
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Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
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Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School Recruiting
Shanghai, Shanghai, China, 200025
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Renji Hospital Affilicated to Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
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Shanghai Zhabei District Shibei Hospital Recruiting
Shanghai, Shanghai, China, 200435
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Tongji Hospital of Tongji University Recruiting
Shanghai, Shanghai, China, 200065
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China, Shanxi
General Hospital of Tisco Recruiting
Taiyuan, Shanxi, China, 030003
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The Third Engineering Bureau Hospital of Ministry of Railway Recruiting
Taiyuan, Shanxi, China, 030006
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Taiyuan City Central Hospital Recruiting
Taiyuan, Shanxi, China, 030009
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Shanxi Cardiovascular Hospital Recruiting
Taiyuan, Shanxi, China, 030024
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China, Sichuan
Chengdu First People's Hospital Recruiting
Chengdu, Sichuan, China, 610016
Contact       ace@dtu.ox.ac.uk   
Chengdu Second People's Hospital Recruiting
Chengdu, Sichuan, China, 610017
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Sichuan Provincial People's Hospital Recruiting
Chengdu, Sichuan, China, 610041
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The West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
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China, Tianjin
Tianjin First Center Hospital Recruiting
Tianjin, Tianjin, China, 300192
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Tianjin Union Hospital Recruiting
Tianjin, Tianjin, China, 300050
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The Fifth Central Hospital of Tianjin Recruiting
Tianjin, Tianjin, China, 300450
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Dagang Oil-Field General Hospital Recruiting
Tianjin, Tianjin, China, 300280
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Tianjin Union Medicine Centre Recruiting
Tianjin, Tianjin, China, 300121
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Army Police's Medical College Affiliated Hospital Recruiting
Tianjin, Tianjin, China, 300162
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Tianjin Chest Hospital Recruiting
Tianjin, Tianjin, China, 300051
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Tianjin Third Central Hospital Recruiting
Tianjin, Tianjin, China, 300170
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The Second Hospital of Tianjin Medical University Recruiting
Tianjin, Tianjin, China, 300211
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China, Xinjiang
First Affiliated Hospital of the Medical College Recruiting
Shihezi, Xinjiang, China, 832008
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The 474th Hospital of PLA Recruiting
Urumqi, Xinjiang, China, 830013
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General Hospital of Xinjiang Production and Construction Corps Recruiting
Urumqi, Xinjiang, China, 830002
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The First Teaching Hospital of Xinjiang Medical University Recruiting
Urumqi, Xinjiang, China, 830054
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China, Yunnan
The First People's Hospital of Yunnan Province Recruiting
Kunming, Yunnan, China, 650032
Contact       ace@dtu.ox.ac.uk   
The Second Affiliated Hospital of Kunming Medical College Recruiting
Kunming, Yunnan, China, 650101
Contact       ace@dtu.ox.ac.uk   
The First Affiliated Hospital of Kunming Medical College Recruiting
Kunming, Yunnan, China, 650032
Contact       ace@dtu.ox.ac.uk   
China, Zhejiang
Zhe Jiang Hospital Recruiting
Hangzhou, Zhejiang, China, 310013
Contact       ace@dtu.ox.ac.uk   
Sir Run Run Shaw Hospital Affiliated With School of Medicine,Zhe Jiang University Recruiting
Hangzhou, Zhejiang, China, 310016
Contact       ace@dtu.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Bayer
Investigators
Principal Investigator: Professor Rury R Holman, FRCP Diabetes Trials Unit, University of Oxford
  More Information

Additional Information:
No publications provided

Responsible Party: Professor Rury Holman, Diabetes Trials Unit, University of Oxford
ClinicalTrials.gov Identifier: NCT00829660     History of Changes
Other Study ID Numbers: 11232, ISRCTN91899513
Study First Received: January 26, 2009
Last Updated: September 27, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by University of Oxford:
Acarbose

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Glucose Intolerance
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014