PROPS - Preventative Role Of a fixed dose combination Pill in Stroke
Research type
Research Study
Full title
PROPS - Preventative Role Of a fixed dose combination Pill in Stroke: A multi-centre open label randomised controlled trial of a fixed dose combination pill versus standard care for secondary prevention of stroke in a primary care setting.
IRAS ID
133678
Contact name
Jonathan Mant
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eudract number
2013-004722-29
ISRCTN Number
ISRCTN58452386
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
Optimal therapy for people who have had a stroke or a Transient Ischaemic Attack (TIA) consists of blood pressure (BP) lowering, cholesterol lowering and anti-platelet agents to reduce risk of further cerebrovascular events. However many people after stroke do not stay on these medications in the long term - a recent review of GP data found 37% of people on stroke registers were not on any cholesterol lowering treatment, and 31% were not on any antihypertensive. In addition, uptake is particularly poor for elderly patients because of the number of separate tablets that need to be taken. With a view to address the above issues, a fixed dose combination (FDC) pill has been developed which combines BP and cholesterol lowering and anti-platelet agents in one pill. This allows a reduction in the number of pills taken and has the potential to improve secondary prevention for these patients. The purpose of this study is to determine whether an FDC pill has a role for secondary prevention of vascular events in older people who have had a stroke/TIA, in a primary care setting.
1222 eligible patients aged 55 and over will be identified by electronic searches of 100 GP surgery databases in the UK and invited by the practice to participate. Following baseline measurement eligible patients will be randomised to either standard care or the FDC pill (Trinomia; containing rampiril 5mg, atorvastatin 20mg, aspirin 100mg) for 25 weeks. The primary outcome is systolic BP; secondary outcomes include cholesterol (total, HDL, non-HDL), diastolic BP, quality of life, side effects, subjective and objective measures of adherence, lifestyle measures, costs, cardiovascular and other relevant events. The primary objective is to determine whether the FDC pill will be non-inferior (as good as) in terms of systolic BP when compared with standard care.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0277
Date of REC Opinion
21 Jul 2015
REC opinion
Further Information Favourable Opinion