NCT00829660

Acarbose Cardiovascular Evaluation Trial

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,526 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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 established coronary heart disease or acute coronary syndrome who have impaired glucose tolerance.

Conditions

• Coronary Heart Disease
• Acute Coronary Syndrome
• Impaired Glucose Tolerance
• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Acarbose	The participants were given one tablet (50mg) of acarbose per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day (50mg twice a day i.e. 100mg/day) and then three tablets/day (50mg three times a day i.e. 150mg/day) thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 150mg/day).
DRUG	Matching Placebo	The participants were given one tablet of matching placebo per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 3 tablets/day).

Timeline

• Start date: 2009-02-17
• Primary completion: 2017-04-11
• Completion: 2017-04-18
• First posted: 2009-01-27
• Last updated: 2017-07-25

Locations

177 sites across 2 countries: China, Hong Kong