Status:
COMPLETED
Acarbose Cardiovascular Evaluation Trial
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Bayer
Conditions:
Coronary Heart Disease
Acute Coronary Syndrome
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 coro...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2017
Estimated Enrollment :
6526 Patients enrolled
Trial Details
Trial ID
NCT00829660
Start Date
February 17 2009
End Date
April 18 2017
Last Update
July 25 2017
Active Locations (177)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230032
2
Beijing Chuiyangliu Hospital
Beijing, Beijing Municipality, China, 100022
3
China Meitan General Hospital
Beijing, Beijing Municipality, China, 100028
4
Beijing Anzhen Hospital of The Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100029