Acarbose Cardiovascular Evaluation Trial
Information source: University of Oxford
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease; Acute Coronary Syndrome; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus (T2DM)
Intervention: Acarbose (Drug); Matching Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Oxford Official(s) and/or principal investigator(s):
Professor Rury R Holman, FRCP, Principal Investigator, Affiliation: Diabetes Trials Unit, University of Oxford
Overall contact:
Professor Rury R Holman, FRCP, Phone: +44 (0) 1865 857240, Email: ace@dtu.ox.ac.uk
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.
Clinical Details
Official title: A Phase IV Trial to Determine Whether Reducing Post-Prandial Glycaemia Can Reduce Cardiovascular-Related Morbidity in Patients With Established Coronary Heart Disease or Acute Coronary Syndrome Who Have Impaired Glucose Tolerance.
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Occurrence of any of the following;
Cardiovascular death,
Non-fatal MI,
Non-fatal stroke
Secondary outcome: Transition to type 2 diabetesAll cause mortality Cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for
heart failure or hospitalization for unstable angina. Evidence of NAFLD Impaired renal function
Detailed description:
A 4-year, multi-centre, double-blind, randomised parallel-group trial to determine whether
reducing post-prandial glycaemia can reduce cardiovascular-related morbidity in patients
with established coronary heart disease or acute coronary syndrome who have impaired glucose
tolerance.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female, aged 50 years or more.
- Definite CHD, defined as a, b or c below:
- Previous myocardial infarction (MI), but not within the last 3 months, with all of
the following:
- Typical clinical presentation
- Confirmatory ECG changes
- Appropriate elevation of cardiac enzymes/biomarkers
- Previous unstable angina, but not within the last 3 months, with all of the
following:
- Typical clinical presentation
- Dynamic ECG changes
- Either elevation of a cardiac biomarker or a >50% stenosis in ≥1 major
epicardial coronary artery shown on coronary angiography
- Current stable angina with both of the following:
- Current and typical clinical history
- A >50% stenosis in ≥1 major epicardial coronary artery shown on coronary
angiography
- 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.
- 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, 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.
- 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
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.
- Known intolerance to alpha glucosidase inhibitors or gastrointestinal problems.
Locations and Contacts
Professor Rury R Holman, FRCP, Phone: +44 (0) 1865 857240, Email: ace@dtu.ox.ac.uk
PLA General Hospital, Beijing 100853, China; Recruiting
Email: ace@dtu.ox.ac.uk
Additional Information
Diabetes Trials Unit, International Co-ordinating Centre for the ACE Trial
Starting date: February 2009
Ending date: October 2014
Last updated: April 23, 2009
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