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Acarbose Cardiovascular Evaluation



To download the final version of the protocol click here, and the Mandarin version here

Protocol Overview

A Mandarin version of this overview is available

ACE is a double-blind, randomised, multi-centre, secondary cardiovascular intervention study coordinated by the University of Oxford Diabetes Trials Unit (DTU).  It was designed by Professor Rury Holman from Oxford University, UK, together with Professor Hu Dayi from People's Hospital Peking University and Professor Pan Changyu from the Chinese PLA General Hospital, Beijing, China.  ACE, which is being conducted in mainland China and Hong Kong, commenced in 2008.  It is an event driven trial with participants being followed up until 728 of them have had primary composite cardiovascular outcome confirmed by adjudication. The ACE Project Office in Beijing fulfils a regional coordinating role.

Recruitment was completed in October 2015 with 6526 participants randomised.

Study Objectives

ACE aims to determine whether acarbose can reduce cardiovascular-related morbidity and mortality in patients with impaired glucose tolerance (IGT) who also have established cardiovascular disease (CVD). Secondary objectives include determining whether acarbose can prevent or delay transition to type 2 diabetes mellitus (T2DM) in this patient population. 

Primary Endpoint

This is a 5-point MACE composite cardiovascular outcome, defined as the time after randomisation to the first occurrence of any one of the following:

Secondary Endpoints

Study Population

Study Treatments

CVD therapy was fully optimised during the run-in period to conform with international guidelines. Patients were then randomised to one of the following two regimens:

A 'Start low, Go slow' dose titration scheme was used. By the third week post-randomisation patients should have been fully titrated and were required to take one tablet three times daily with meals.  

Assessment Periods

Patients will attend study visits every four months post randomisation.

Sample Size Estimation

Assuming:

For 85% power the study will require 6,300 patients, i.e. 3,150 per group, with a minimum of 728 adjudicated primary events. A total of 6,500 patients will be recruited to allow for a possible 3% loss-to-follow up.