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