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Coronary Heart DiseasePhase 4ACENCT00829660

Acarbose Cardiovascular Evaluation Trial

A Phase 4 study testing Acarbose in people with Coronary Heart Disease and Acute Coronary Syndrome, run by University of Oxford at 177 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Acarbose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,526 participants
Where
177 sitesin 2 countries
Study dates
17 Feb 2009to 18 Apr 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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.

Who cannot join

  • 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)
Show all 11Show fewer
  • 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.

Trial locations and contacts

177 sites in 2 countries.

177 sites in 2 countries

China176 sites

  • The Central Hospital of Anshan

    Anshan, Liaoning, 114001

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014010

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014040

  • Beijing Chuiyangliu Hospital

    Beijing, Beijing Municipality, 100022

  • China Meitan General Hospital

    Beijing, Beijing Municipality, 100028

  • Beijing Anzhen Hospital of The Capital University of Medical Sciences

    Beijing, Beijing Municipality, 100029

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Ji Shui Tan Hospital

    Beijing, Beijing Municipality, 100035

  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality, 100038

  • Fu Xing Hospital

    Beijing, Beijing Municipality, 100038

  • Beijing Shijingshan Hospital

    Beijing, Beijing Municipality, 100043

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Aerospace Central Hospital

    Beijing, Beijing Municipality, 100049

  • Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

  • Wangjing Hospital of CACMS

    Beijing, Beijing Municipality, 100053

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Healthy Palace Hospital

    Beijing, Beijing Municipality, 100054

  • Aerospace 731 Hospital

    Beijing, Beijing Municipality, 100074

  • General Hospital of Second Artillery PLA

    Beijing, Beijing Municipality, 100088

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • Anzhen Hospital of The Capital University of Medical Sciences 2nd.

    Beijing, Beijing Municipality, 101200

  • Beijing Pinggu Hospital

    Beijing, Beijing Municipality, 101200

  • Beijing Yanhua Hospital

    Beijing, Beijing Municipality, 102500

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 062650

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • The Fourth Hospital of Changsha

    Changsha, Hunan, 410006

  • Xiangya Hospital Central-South University

    Changsha, Hunan, 410008

  • The Third Hospital of Changsha

    Changsha, Hunan, 410015

  • Chengdu First People's Hospital

    Chengdu, Sichuan, 610016

  • Chengdu Second People's Hospital

    Chengdu, Sichuan, 610017

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610041

  • The West China Hospital

    Chengdu, Sichuan, 610041

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia, 024000

  • Chongqing Medical University Second Afflicated Hospital

    Chongqing, Chongqing Municipality, 400010

  • Chongqing Zhongshan Hospital

    Chongqing, Chongqing Municipality, 400013

  • Chongqing Third People's Hospital

    Chongqing, Chongqing Municipality, 400014

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Da Ping Hospital

    Chongqing, Chongqing Municipality, 400042

  • The Second People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, 402160

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

  • The First Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Dalian Central Hospital

    Dalian, Liaoning, 116033

  • Da Qing Oilfield General Hospital

    Daqing, Heilongjiang, 163001

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou, Fujian, 350001

  • The People's Hospital of Fujian Province

    Fuzhou, Fujian, 350004

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • The Third Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong, 510150

  • Wu Jing Zhong Dui Hospital of Guangdong Province

    Guangzhou, Guangdong, 510507

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630

  • The Affiliated Hospital of Guiyang Medical College

    Guiyang, Guizhou, 550004

  • Zhe Jiang Hospital

    Hangzhou, Zhejiang, 310013

  • Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhe Jiang University

    Hangzhou, Zhejiang, 310016

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230032

  • Inner Mongolia Hospital

    Hohhot, Inner Mongolia, 010017

  • The Central Hospital of Jinan

    Jinan, Shandong, 250013

  • The First People's Hospital of Jinan

    Jinan, Shandong, 250013

  • The General Hospital of Jinan Military Region

    Jinan, Shandong, 250031

  • Jiujiang University Hospital

    Jiujiang, Jiangxi, 332000

  • The First Affiliated Hospital of Kunming Medical College

    Kunming, Yunnan, 650032

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650032

  • The Second Affiliated Hospital of Kunming Medical College

    Kunming, Yunnan, 650101

  • Linyi People's Hospital

    Linyi, Shandong, 276003

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545005

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545006

  • The First Affiliated Hospital of Henan Science & Technology University

    Luoyang, Henan, 471003

  • Luo Yang Central Hospital, Affiliated to Zhengzhou University

    Luoyang, Henan, 471009

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Third Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330008

  • 81st Hospital of Chinese PLA

    Nanjing, Jiangsu, 210002

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Nanjing Zhongda Hospital

    Nanjing, Jiangsu, 210009

  • BENQ Hospital

    Nanjing, Jiangsu, 210017

  • Jiangsu Province Official Hospital

    Nanjing, Jiangsu, 210024

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Jiangsu Provincial Hospital of TCM

    Nanjing, Jiangsu, 210029

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 211100

  • Minzu Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530001

  • 303 Hospital of People's Liberation Army

    Nanning, Guangxi, 530021

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Hospital Affiliated of Medical School, Qingdao University

    Qingdao, Shandong, 266003

  • The Qingdao Municiple Hospital

    Qingdao, Shandong, 266011

  • Shanghai Ninth People's Hospital

    Shanghai, Shanghai Municipality, 200011

  • Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School

    Shanghai, Shanghai Municipality, 200025

  • Shanghai Central Hospital of Xuhui District

    Shanghai, Shanghai Municipality, 200031

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Huadong Hospital

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Putuo District People's Hospital

    Shanghai, Shanghai Municipality, 200060

  • Putuo District Center Hospital

    Shanghai, Shanghai Municipality, 200062

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

  • Number 411 Hospital of PLA

    Shanghai, Shanghai Municipality, 200081

  • Shanghai Central Hospital of Yangpu District

    Shanghai, Shanghai Municipality, 200090

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

  • Renji Hospital Affilicated to Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

  • Shanghai Pudong New Area Gongli Hospital

    Shanghai, Shanghai Municipality, 200135

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • Shanghai Zhabei District Shibei Hospital

    Shanghai, Shanghai Municipality, 200435

  • Shanghai Jinshan Hospital

    Shanghai, Shanghai Municipality, 200540

  • Shanghai Pudong New District People's Hospital

    Shanghai, Shanghai Municipality, 201200

  • Xianyang Central Hospital

    Shengyang, Liaoning, 712000

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110016

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110021

  • The Fourth Hospital of China Medical University

    Shenyang, Liaoning, 110032

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Qingdao Fuwai Hospital

    Shibei, Shandong, 266034

  • First Affiliated Hospital of the Medical College

    Shihezi, Xinjiang, 832008

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

  • Bethune International Peace Hospital

    Shijiazhuang, Hebei, 050082

  • Sichuan Mianyang 404 Hospital

    Sichuan, Sichuan, 621000

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215000

  • Taian City Central Hospital

    Taian, Shandong, 271000

  • General Hospital of Tisco

    Taiyuan, Shanxi, 030003

  • The Third Engineering Bureau Hospital of Ministry of Railway

    Taiyuan, Shanxi, 030006

  • Taiyuan City Central Hospital

    Taiyuan, Shanxi, 030009

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030024

  • Tangshan Workers Hospital

    Tangshan, Hebei, 063000

  • The Affiliated Hospital of North China Coal Medical University

    Tangshan, Hebei, 063000

  • Yu Tian County Hospital

    Tangshan, Hebei, 064100

  • Tianjin Union Hospital

    Tianjin, Tianjin Municipality, 300050

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300051

  • Tianjin Union Medicine Centre

    Tianjin, Tianjin Municipality, 300121

  • Army Police's Medical College Affiliated Hospital

    Tianjin, Tianjin Municipality, 300162

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality, 300170

  • Tianjin First Center Hospital

    Tianjin, Tianjin Municipality, 300192

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • Dagang Oil-Field General Hospital

    Tianjin, Tianjin Municipality, 300280

  • The Fifth Central Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300450

  • Xin Jiang Traditional Chinese Medicine Hospital

    Ürümqi, Xinjiang, 830000

  • General Hospital of Xinjiang Production and Construction Corps

    Ürümqi, Xinjiang, 830002

  • The 474th Hospital of PLA

    Ürümqi, Xinjiang, 830013

  • The First Teaching Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Union Hospital of Tongji Medical College of Huazhong

    Wuhan, Hubei, 430022

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022

  • Tongji Hospital of Tongji Medical College of Huazhong

    Wuhan, Hubei, 430030

  • Pu'ai Hospital of Wuhan City

    Wuhan, Hubei, 430033

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu, 214002

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • Wuxi No.3 People's Hospital

    Wuxi, Jiangsu, 214041

  • Xi'an Central Hospital

    Xi'an, Shaanxi, 710003

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Affiliated Hospital of Xi'an Medical college

    Xi'an, Shaanxi, 710077

  • PLA No.323 Hospital

    Xi’an, Shanxi, 710054

  • The First Hospital of Xiamen

    Xiamen, Fujian, 361003

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • Hospital Affiliated Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • The Second Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

  • Affiliated Hospital of Yan'an University

    Yan’an, Shaanxi, 716000

  • Yan'an People's Hospital

    Yan’an, Shaanxi, 716000

  • The First Hospital of Yinchuan

    Yinchuan, Ningxia, 750001

  • Affiliated Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • The People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, 750021

  • The First Hospital of Yulin

    Yulin, Shaanxi, 719000

  • People's Hospital of Yuxi City

    Yuxi, Yunnan, 653100

  • The Third Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei, 075000

  • The First Affiliated Hospital of Henan College of TCM

    Zhengzhou, Henan, 450000

  • The People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450003

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

  • Zhenjiang First People's Hospital

    Zhenjiang, Jiangsu, 212002

  • Zhong Shan City People's Hospital

    Zhongshan, Guangdong, 528403

  • The Fifth Affiliated Hospital of Sun Yat-Sen University

    Zhuhai, Guangdong, 519000

Other trials in China

Hong Kong1 site

  • Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
Acarbose, Matching Placebo
Keywords
Acarbose
Medical subject headings
Coronary Disease, Acute Coronary Syndrome, Glucose Intolerance, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcarboseDrug

    Also called Glucobay

    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).

  • Matching PlaceboDrug

    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).

Study groups in NCT00829660
Study groupRoleWhat they receive
AcarboseActive comparatorThe 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).
Receives: Drug: Acarbose
Matching PlaceboPlacebo comparatorThe 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).
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Follow-up until 728 adjudicated Primary Outcome Measures have been recorded

Secondary outcomes (6)

  1. 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.

  2. All cause mortality

  3. Each of the components of the primary composite cardiovascular outcome will also be analysed individually, both as first and as total events.

  4. 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

  5. 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

  6. Resource use, costs and cost effectiveness

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2009 (estimated)
  2. Study start17 Feb 2009
  3. Primary completion11 Apr 2017
  4. Study completion18 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00829660
Sponsor's protocol ID
11232
Other IDs
ISRCTN91899513
Acronym
ACE
Status last verified
Jul 2017
First submitted
26 Jan 2009
Last updated
25 Jul 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33035598

  • 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.

    PubMed 32641379

  • 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.

    PubMed 28917545

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acarbose in people with Coronary Heart Disease and Acute Coronary Syndrome, run by University of Oxford at 177 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00829660, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.

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