MRC/BHF Heart Protection Study
Research type
Research Study
Full title
A randomised study of the effects on mortality and morbidity of HMG CoA reductase inhibitors and of antioxidant vitamins in a wide range of people at high risk of coronary heart disease.
IRAS ID
262231
Contact name
n/a n/a
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
ISRCTN48489393, ISRCTN registration number
Duration of Study in the UK
66 years, 11 months, 31 days
Research summary
The MRC/BHF Heart Protection Study (HPS) was a large randomised controlled trial. Between 1994-1997, 20,536 individuals at increased risk of coronary heart disease were randomised to 40 mg simvastatin daily versus matching placebo, and (in a 2X2 factorial design) to anti-oxidant vitamin supplementation with vitamins E, C and beta-carotene versus placebo. Participants remained on the trial medications for an average 5 years (scheduled treatment period), and the trial closed in 2001.
Follow-up of all surviving HPS participants has continued after the end of the scheduled treatment period. Initially, annual questionnaires were sent to the surviving participants between 2001-2007, and this follow-up was supplemented with cause-specific mortality data provided by ONS and incident cancers via national cancer registries. Additionally, and with the necessary approvals, Hospital Episodes Statistics (HES) data was provided by the NHS Information Centre (now called NHS Digital), thereby providing details on non-fatal events occurring in the HPS study population.The aim was to study the overall effects on survival by preventing heart attacks, strokes and other major vascular events. The main results of HPS showed clearly that allocation to cholesterol-lowering therapy with simvastatin was associated with a 20% reduction in the risk of heart attacks and stroke and a reduction in all-cause mortality, chiefly driven by a very significant reduction in vascular deaths. These results changed clinical practice worldwide, and statins are now prescribed widely to many millions of patients.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0262
Date of REC Opinion
24 Apr 2019
REC opinion
Favourable Opinion