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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN91899513
Date of registration: 12/11/2008
Primary sponsor: University of Oxford (UK)
Public title: Acarbose Cardiovascular Evaluation Trial ACE
Scientific title: The Acarbose Cardiovascular Evaluation (ACE) Trial: A 4-year, 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
Date of first enrolment: Dec 15 2008
Target sample size: 7,500
Recruitment status: Ongoing/Recruiting
URL:  http://isrctn.org/ISRCTN91899513
Study type:  Interventional
Study design:  Phase IV multi-centre double-blind randomised controlled clinical outcome trial  
Countries of recruitment
China
Contacts
Name: Rury  Holman
Address:  Diabetes Trials Unit Oxford Centre for Diabetes, Endocrinology and Metabolism (OCDEM) Churchill hospital Old Road Headington OX3 7LJ Oxford United Kingdom
Telephone: +44 (0)1865 857240
Email: ace@dtu.ox.ac.uk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/09/2011:
1. Male or female, aged 50 years or more
2. Definite CHD, defined as a, b or c below:
2.1 Previous myocardial infarction (MI) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following:
2.1.1. Typical clinical presentation
2.1.2. Confirmatory ECG changes
2.1.3. Appropriate elevation of cardiac enzymes/biomarkers
Note: Patients with stents are eligible.
2.2 Previous unstable angina (UA) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following:
2.2.1. Typical clinical presentation
2.2.2.Confirmatory ECG changes
2.2.3.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.
2.3. Current stable angina defined as:
2.3.1. Typical clinical history with symptoms occurring within the last month, and
2.3.2. 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.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.
4. Optimised cardiovascular drug therapy
5. At least 80% adherent to single blind placebo Study Medication during the run-in period
6. Provision of written informed consent

Previous inclusion criteria as of 02/03/10:

2.1. Previous myocardial infarction (MI), but not within the last 3 months, with at least two of the following:
2.2 Previous unstable angina, but not within the last 3 months, with all of the following:
2.2.1. Typical clinical presentation
2.2.2. Dynamic ECG changes
2.2.3. Either elevation of a cardiac biomarker or a >50% stenosis in =1 major epicardial coronary artery shown on coronary angiography
2.3. Current stable angina defined as:
2.3.1. Typical clinical history with symptoms occurring within the last month, and
2.3.2. A >50% stenosis in =1 major epicardial coronary artery shown on coronary angiography
3. 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

Previous inclusion criteria at time of registration:
1. Male or female, aged 50 years or more
2. Definite CHD, defined as a, b or c below:
2.1. Previous myocardial infarction (MI), but not within the last 3 months, with all of the following:
2.1.1. Typical clinical presentation
2.1.2. Confirmatory electrocardiogram (ECG) changes
2.1.3. Appropriate elevation of cardiac enzymes/biomarkers
2.2. Previous unstable angina, but not within the last 3 months, with all of the following:
2.2.1. Typical clinical presentation
2.2.2. Dynamic ECG changes
2.2.3. Either elevation of a cardiac biomarker or a >50% stenosis in >=1 major epicardial coronary artery shown on coronary angiography
2.3. Current stable angina with both of the following:
2.3.1. Current and typical clinical history
2.3.2. A >50% stenosis in >=1 major epicardial coronary artery shown on coronary
angiography
3. Impaired glucose tolerance diagnosed on a single 75 g 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
4. Optimised cardiovascular drug therapy
5. At least 80% adherent to single-blind placebo Study Medication during the run-in period
6. Provision of written informed consent

Exclusion criteria: Current information as of 02/03/10:
1. Previous history of diabetes, other than gestational diabetes.
2. MI, unstable angina, stroke or a transient ischaemic attack (TIA) within the previous three months.
3. Planned or anticipated coronary, cerebrovascular or peripheral arterial revascularisation or other major surgical intervention.
4. New York Heart Association (NYHA) class III or IV heart failure.
5. Evidence of severe hepatic disease.
6. Evidence of severe renal impairment or an eGFR <30 ml/min/1.73m2 (derived using the MDRD Chinese equation)
7. 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.
8. Pregnancy (or planned pregnancy within the next five years).
9. Concurrent participation in any other clinical interventional trial.
10. Known intolerance to alpha glucosidase inhibitors or gastrointestinal problems.
11. Thought by the investigator for any reason to be unsuitable for participation in this clinical study.

Initial information at time of registration:
1. Previous history of diabetes, other than gestational diabetes
2. MI, stroke or a transient ischaemic attack (TIA) within the previous three months
3. Planned or anticipated coronary, cerebrovascular or peripheral arterial revascularisation or other major surgical intervention
4. New York Heart Association (NYHA) class III or IV heart failure
5. Evidence of severe hepatic disease
6. Evidence of severe renal impairment or an estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m^2 (derived using the MDRD Chinese equation)
7. 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
8. Pregnancy (or planned pregnancy within the next five years)
9. Concurrent participation in any other clinical interventional trial
10. Known intolerance to alpha glucosidase inhibitors or gastrointestinal problems
11. Thought by the investigator for any reason to be unsuitable for participation in this clinical study


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Coronary heart disease, acute coronary syndrome, impaired glucose tolerance, type 2 diabetes mellitus
Intervention(s)
Acarbose (oral) vs placebo.

The participants in the intervention group will be given one tablet (50 mg) of acarbose per day to be taken with a meal during the first week (7 days). During the second week, the dose is increased to two tablets/day (50 mg twice a day; 100 mg/day), and then three tablets/day (50 mg three times a day; 150 mg/day) thereafter. The maximum tolerated dose will be taken for the duration of the trial (maximum dose is 150 mg/day).

Total duration of interventions: Approximately four years
Primary Outcome(s)
Occurrence of any one of the following:
1. Cardiovascular death
2. Non-fatal MI
3. Non-fatal stroke

The primary and secondary outcomes will be monitored for a minimum of 4 years/participant. The outcomes will be assessed at 1, 2 and 4 months post-randomisation, and then every 4 months thereafter for the remainder of the trial.
Secondary Outcome(s)
Current information as of 02/03/10:
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. Composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalisation for heart failure or hospitalisation for unstable angina. Each of the components of this composite will also be analysed individually, both as first and as total events.
4. Proportion of patients with evidence of non-alcoholic fatty liver disease (NAFLD) as judged by changes in ALT levels
5. Proportion of patients with an impaired renal function as evidenced by:
A reduced eGFR (<30 ml/minute/ 1.73 m2) estimated using the Chinese MDRD formula, or a doubling of the baseline plasma creatinine level, or a halving of the baseline eGRF

The primary and secondary outcomes will be monitored for a minimum of 4 years/participant. The outcomes will be assessed at 1, 2 and 4 months post-randomisation, and then every 4 months thereafter for the remainder of the trial.

Initial information at time of registration:
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. Composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalisation for heart failure or hospitalisation for unstable angina. Each of the components of this composite will also be analysed individually, both as first and as total events.
4. Proportion of patients with evidence of non-alcoholic fatty liver disease (NAFLD) as judged by changes in alanine aminotransferase (ALT) levels
5. Proportion of patients with an impaired renal function as evidenced by a reduced eGFR (<60 ml/minute/1.73 m^2) estimated using the Chinese MDRD formula, or a doubling of the baseline plasma creatinine level

The primary and secondary outcomes will be monitored for a minimum of 4 years/participant. The outcomes will be assessed at 1, 2 and 4 months post-randomisation, and then every 4 months thereafter for the remainder of the trial.
Secondary ID(s)
11232
NCT00829660
Source(s) of Monetary Support
Bayer Schering Pharma (UK)
Secondary Sponsor(s)
N/A
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