acarbose cardiovascular evaluation trial

Conditions: Coronary Heart Disease; Acute Coronary Syndrome; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus (T2DM)

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.

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.

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.

Keywords: acarbose