Trial Design
Rationale for and design of the Acarbose Cardiovascular Evaluation (ACE) trial

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Patients with cardiovascular disease and impaired glucose tolerance are at increased risk of cardiovascular events and type 2 diabetes mellitus (T2DM). Lifestyle modification or pharmacological intervention can delay progression to T2DM, but there is no clear evidence that they reduce cardiovascular risk in this population. Acarbose, an α-glucosidase inhibitor that lowers postprandial blood glucose, has been shown to reduce T2DM risk by 25%, and possibly cardiovascular risk in impaired glucose tolerance subjects without cardiovascular disease.

Section snippets

Trial design

ACE is a randomized, controlled, double-blind, multi-center clinical trial conducted in the People’s Republic of China and Hong Kong, which commenced in February 2009. It is performed in accordance with the International Conference on Harmonisation Good Clinical Practice standards, local laws, regulations and organizations, and ethical approval from the Oxford Tropical Research Ethics Committee. Documented approval from appropriate ethics committees and institutional review boards is obtained

Discussion

A number of observational studies and meta-analyses have suggested that elevated postprandial plasma glucose levels could increase the risk of developing cardiovascular disease. This hypothesis gained further support from the randomized double-blind placebo-controlled STOP-NIDDM trial35, 36 in which subjects with IGT given acarbose to reduce postprandial hyperglycemia, were shown in a secondary analysis to have a lower risk of cardiovascular events.

The ACE trial was designed to evaluate whether

Acknowledgements

The ACE study is funded by an unrestricted grant from Bayer. RRH is a National Institute for Health Research (NIHR) Senior Investigator. See online Appendix for Disclosures and Trial Organization.

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