A Study of Cardiovascular Events iN Diabetes PLUS (ASCEND PLUS)

Research summary

The ASCEND PLUS trial aims assess whether treatment with oral semaglutide reduces the risk of cardiovascular events,and other complications of diabetes,in individuals aged at least 55 years,with type 2 diabetes,without a history of a myocardial infarction or stroke,and without any upper or lower HbA1c threshold. The trial will use mail-based invitation to randomise approximately 20,000 people with type 2 diabetes,and no history of myocardial infarction or stroke,all recruited within the UK and follow them during a scheduled treatment period with a median duration of approximately 5 years and the subsequent 20 years. There will be no physical sites,and all interactions with participants will be conducted directly using innovative patient-centred web-based technology,or by telephone pr video call,supplemented by mailed letters. Study treatment will be mailed to participants. The primary outcome is the expanded composite of major adverse cardiovascular events (MACE+,defined as death from cardiovascular disease,non-fatal myocardial infarction,non-fatal stroke,transient ischaemic attack [TIA] and coronary revascularisation) during the scheduled treatment period. Central to the conduct of the ASCEND PLUS trial will be its reliance on the efficient collection of relevant data via regular linkage to NHS datasets and registries,supplemented where necessary by data collected from participants and from other healthcare professionals.

Principal Investigator

Dr Rustam Rea

Contact us

Email: diabetes.research1@ouh.nhs.uk

IRAS number

1004252