Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00829660
Eligibility 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:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00829660
Study Brief:
Protocol Section:
NCT00829660