SHARP Post-Trial Follow-Up
Research type
Research Study
Full title
Study of Heart and Renal Protection (SHARP) Post-Trial Follow-Up (PTFU)
IRAS ID
83158
Contact name
Colin Baigent
Contact email
Sponsor organisation
The University of Oxford
Eudract number
2004-001156-31
ISRCTN Number
ISRCTN54137607
Clinicaltrials.gov Identifier
Duration of Study in the UK
25 years, 0 months, 0 days
Research summary
The SHARP trial was set up to determine whether lowering 'bad' cholesterol (known as LDL-cholesterol) is beneficial in patients with chronic kidney disease (CKD). SHARP study participants were randomly allocated to take either cholesterol-lowering therapy (a combination tablet containing simvastatin 20mg plus ezetimibe 10mg daily), or "placebo" (a matching dummy tablet) for an average of 5 years. The SHARP trial finished in 2010 and concluded that around a quarter of all heart attacks, strokes and operations to open blocked arteries could be avoided in people with CKD by using the combination tablet to lower blood cholesterol levels.
The aim of this project is to carry out extended follow-up of SHARP participants to determine whether, in the longer-term:
(i) the beneficial effects in reducing the risk of heart attacks, strokes and operations to open blocked arteries seen in SHARP persist;
(ii) there is any protective effect on the kidneys;
(iii) any hazardous effects (such as cancer) emerge.
This will be done by analyzing data routinely reported into UK clinical databases (known as registries) from when the SHARP trial ended in 2010. It will not involve any input from the original UK trial participants, i.e. the extended follow-up will not involve taking any further study medication or attending any study visits.REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0001
Date of REC Opinion
31 Jan 2018
REC opinion
Favourable Opinion