Acarbose Cardiovascular Evaluation Trial
- Conditions
- Type 2 Diabetes Mellitus (T2DM)Coronary Heart DiseaseAcute Coronary SyndromeImpaired Glucose Tolerance
- Interventions
- Drug: Matching Placebo
- Registration Number
- NCT00829660
- Lead Sponsor
- University of Oxford
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6526
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching 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). Acarbose 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).
- Primary Outcome Measures
Name Time Method 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 Follow-up until 728 adjudicated Primary Outcome Measures have been recorded
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (176)
Shanghai Zhabei District Shibei Hospital
🇨🇳Shanghai, Shanghai, China
China Meitan General Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Beijing Shijingshan Hospital
🇨🇳Beijing, Beijing, China
Beijing Healthy Palace Hospital
🇨🇳Beijing, Beijing, China
General Hospital of Second Artillery PLA
🇨🇳Beijing, Beijing, China
PLA General Hospital
🇨🇳Beijing, Beijing, China
303 Hospital of People's Liberation Army
🇨🇳Nanning, Guangxi, China
Pu'ai Hospital of Wuhan City
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Baotou Central Hospital
🇨🇳Baotou, Inner Mongolia, China
The Second Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Central Hospital of Anshan
🇨🇳Anshan, Liaoning, China
The First Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Xianyang Central Hospital
🇨🇳Shengyang, Liaoning, China
Affiliated Hospital of Yan'an University
🇨🇳Yan'an, Shaanxi, China
Affiliated Hospital of Xi'an Medical college
🇨🇳Xi'an, Shaanxi, China
The General Hospital of Jinan Military Region
🇨🇳Jinan, Shandong, China
Hospital Affiliated of Medical School, Qingdao University
🇨🇳Qingdao, Shandong, China
Qingdao Fuwai Hospital
🇨🇳Shibei, Shandong, China
Shanghai Ninth People's Hospital
🇨🇳Shanghai, Shanghai, China
Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School
🇨🇳Shanghai, Shanghai, China
Shanghai Central Hospital of Xuhui District
🇨🇳Shanghai, Shanghai, China
Shanghai Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Huadong Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Putuo District People's Hospital
🇨🇳Shanghai, Shanghai, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Number 411 Hospital of PLA
🇨🇳Shanghai, Shanghai, China
Shanghai Central Hospital of Yangpu District
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Renji Hospital Affilicated to Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Pudong New Area Gongli Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Jinshan Hospital
🇨🇳Shanghai, Shanghai, China
General Hospital of Tisco
🇨🇳Taiyuan, Shanxi, China
Taiyuan City Central Hospital
🇨🇳Taiyuan, Shanxi, China
PLA No.323 Hospital
🇨🇳Xi'an, Shanxi, China
Chengdu First People's Hospital
🇨🇳Chengdu, Sichuan, China
Chengdu Second People's Hospital
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The West China Hospital
🇨🇳Chengdu, Sichuan, China
Sichuan Mianyang 404 Hospital
🇨🇳Sichuan, Sichuan, China
Tianjin Union Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Union Medicine Centre
🇨🇳Tianjin, Tianjin, China
Tianjin First Center Hospital
🇨🇳Tianjin, Tianjin, China
Xin Jiang Traditional Chinese Medicine Hospital
🇨🇳Urumqi, Xinjiang, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
Dagang Oil-Field General Hospital
🇨🇳Tianjin, Tianjin, China
The Fifth Central Hospital of Tianjin
🇨🇳Tianjin, Tianjin, China
General Hospital of Xinjiang Production and Construction Corps
🇨🇳Urumqi, Xinjiang, China
The 474th Hospital of PLA
🇨🇳Urumqi, Xinjiang, China
The First Teaching Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical College
🇨🇳Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
The Second Affiliated Hospital of Kunming Medical College
🇨🇳Kunming, Yunnan, China
People's Hospital of Yuxi City
🇨🇳Yuxi, Yunnan, China
Beijing Ji Shui Tan Hospital
🇨🇳Beijing, Beijing, China
Minzu Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Hebei North University
🇨🇳Zhangjiakou, Hebei, China
Da Qing Oilfield General Hospital
🇨🇳Da Qing, Heilongjiang, China
Union Hospital of Tongji Medical College of Huazhong
🇨🇳Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College of Huazhong
🇨🇳Wuhan, Hubei, China
Inner Mongolia Hospital
🇨🇳Hohhot, Inner Mongolia, China
81st Hospital of Chinese PLA
🇨🇳NanJing, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
BENQ Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Provincial Hospital of TCM
🇨🇳NanJing, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Third Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
Jiujiang University Hospital
🇨🇳Jiujiang, Jiangxi, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
Dalian Central Hospital
🇨🇳Dalian, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The Central Hospital of Jinan
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
The Fourth Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The First Hospital of Yinchuan
🇨🇳Yinchuan, Ningxia, China
The First Hospital of Yulin
🇨🇳Yulin, Shaanxi, China
Yan'an People's Hospital
🇨🇳Yanan, Shaanxi, China
Xi'an Central Hospital
🇨🇳Xi'an, Shaanxi, China
The First People's Hospital of Jinan
🇨🇳Jinan, Shandong, China
Linyi People's Hospital
🇨🇳Linyi, Shandong, China
The Qingdao Municiple Hospital
🇨🇳Qingdao, Shandong, China
Putuo District Center Hospital
🇨🇳Shanghai, Shanghai, China
Shanxi Cardiovascular Hospital
🇨🇳Taiyuan, Shanxi, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Pudong New District People's Hospital
🇨🇳Shanghai, Shanghai, China
The Third Engineering Bureau Hospital of Ministry of Railway
🇨🇳Taiyuan, Shanxi, China
Army Police's Medical College Affiliated Hospital
🇨🇳Tianjin, Tianjin, China
Changhai Hospital
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital of the Medical College
🇨🇳Shihezi, Xinjiang, China
Zhe Jiang Hospital
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhe Jiang University
🇨🇳Hangzhou, Zhejiang, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Anzhen Hospital of The Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Chuiyangliu Hospital
🇨🇳Beijing, Beijing, China
Beijing Shijitan Hospital
🇨🇳Beijing, Beijing, China
Aerospace Central Hospital
🇨🇳Beijing, Beijing, China
Fu Xing Hospital
🇨🇳Beijing, Beijing, China
Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Wangjing Hospital of CACMS
🇨🇳Beijing, Beijing, China
Aerospace 731 Hospital
🇨🇳Beijing, Beijing, China
Beijing Pinggu Hospital
🇨🇳Beijing, Beijing, China
Chongqing Medical University Second Afflicated Hospital
🇨🇳Chongqing, Chongqing, China
Anzhen Hospital of The Capital University of Medical Sciences 2nd.
🇨🇳Beijing, Beijing, China
Chongqing Zhongshan Hospital
🇨🇳Chongqing, Chongqing, China
Beijing Yanhua Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Second People's Hospital of Chongqing
🇨🇳Chongqing, Chongqing, China
The People's Hospital of Fujian Province
🇨🇳Fuzhou, Fujian, China
Chongqing Third People's Hospital
🇨🇳Chongqing, Chongqing, China
Da Ping Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Union Hospital Affiliated to Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Xiamen
🇨🇳Xiamen, Fujian, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Wu Jing Zhong Dui Hospital of Guangdong Province
🇨🇳Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Zhong Shan City People's Hospital
🇨🇳Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-Sen University
🇨🇳Zhuhai, Guangdong, China
Liuzhou Worker's Hospital
🇨🇳Liuzhou, Guangxi, China
The Affiliated Hospital of Guiyang Medical College
🇨🇳Guiyang, Guizhou, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Bethune International Peace Hospital
🇨🇳Shijiazhuang, Hebei, China
Tangshan Workers Hospital
🇨🇳Tangshan, Hebei, China
The Affiliated Hospital of North China Coal Medical University
🇨🇳Tangshan, Hebei, China
Luo Yang Central Hospital, Affiliated to Zhengzhou University
🇨🇳Luoyang, Henan, China
Yu Tian County Hospital
🇨🇳Tangshan, Hebei, China
The First Affiliated Hospital of Henan College of TCM
🇨🇳Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳ZhengZhou, Henan, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan Science & Technology University
🇨🇳Luoyang, Henan, China
The People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
The Fourth Hospital of Changsha
🇨🇳Changsha, Hunan, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central-South University
🇨🇳Changsha, Hunan, China
The Third Hospital of Changsha
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College
🇨🇳Baotou, Inner Mongolia, China
Chifeng Municipal Hospital
🇨🇳Chifeng, Inner Mongolia, China
Nanjing Zhongda Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Official Hospital
🇨🇳NanJing, Jiangsu, China
Nanjing Jiangning Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
Wuxi No.2 People's Hospital
🇨🇳Wuxi, Jiangsu, China
Wuxi No.3 People's Hospital
🇨🇳Wuxi, Jiangsu, China
Hospital Affiliated Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Zhenjiang First People's Hospital
🇨🇳Zhenjiang, Jiangsu, China
Affiliated Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
The People's Hospital of Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia, China
Taian City Central Hospital
🇨🇳Taian, Shandong, China
Tianjin Third Central Hospital
🇨🇳Tianjin, Tianjin, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
The Third Affiliated Hospital of Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong