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
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
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.
Inclusion Criteria:
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:
Previous unstable angina (UA) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following:
Current stable angina defined as:
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:
Beijing, Beijing Municipality 100029, China
Beijing, Beijing Municipality 100050, China
Beijing, Beijing Municipality 101200, China
Chongqing, Chongqing Municipality 400010, China
Chongqing, Chongqing Municipality 400016, China
Guangzhou, Guangdong 510080, China
Shengyang, Liaoning 712000, China
Taian, Shandong 271000, China
Shanghai, Shanghai Municipality 200025, China
Shanghai, Shanghai Municipality 200092, China
Shanghai, Shanghai Municipality 200127, China
Sichuan, Sichuan 621000, China
Hangzhou, Zhejiang 310016, China