Stroke prevention Circulatory System
Conditions
Interventions
Current interventions as of 28/07/2015:
Participants in the intervention arm will receive Trinomia, a fixed dose combination pill, and participants in the control arm will receive standard ('normal')
Sponsors
Cambridge University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 28/07/2015: 1. Men and post-menopausal* women, aged 55 years or over at the point of the database search 2. On the stroke/TIA register of the general practice. *Post-menopausal defined as: no menstrual period for 12 consecutive months or more. Previous inclusion criteria: Participants eligible for the trial must comply with all of the following at randomisation: 1. Age 55 or over 2. On the stroke/TIA register of the general practice
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/07/2015: 1. Confirmed diagnosis of haemorrhagic stroke 2. Currently receiving treatment with more than the equivalent of 20 mg of atorvastatin 3. Currently receiving treatment with clopidogrel anti-platelet monotherapy 4. Currently receiving treatment with anti-coagulant therapy 5. SBP <120mmHg 6. Orthostatic hypotension(=20mmHg postural drop in SBP after 1 minute of standing) 7. Terminal illness 8. Known left ventricular systolic dysfunction (ejection fraction < 30%) 9. Absolute contra-indication to atorvastatin, aspirin or ramipril as specified in the SmPC or British National Formulary (BNF) or hypersensitivity to these components 10. Inability to give informed consent 11. Deemed unsuitable by General Practitioner (GP) for other reasons 12. Women of child bearing potential 13. Unable to swallow tablets or capsules Involvement in any other trial is not an exclusion criterion. Previous exclusion criteria: 1. On 3 or more antihypertensive agents 2. On more than the equivalent of 40mg simvastatin 3. Systolic blood pressure < 120mmHg 4. Orthostatic hypotension (=20mmHg drop in systolic blood pressure on standing measured after 1 minute of standing) 5. Terminal illness 6. Heart failure 7. Absolute contra-indication to any of the components of the 'polypill' 8. Inability to give informed consent and without a designated representative who is able to provide consent under the terms of the Mental Capacity Act 2008 9. Deemed unsuitable by General Practitioner (GP) for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 28/07/2015: Systolic blood pressure at baseline and follow-up at 25 weeks Previous primary outcome measures: To determine whether a 'polypill' will be non-inferior in terms of systolic blood pressure when compared with standard care in people with a history of stroke/TIA in a Primary Care setting over a period of six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 28/07/2015: 1. Non-HDL, HDL & total cholesterol (baseline and follow-up at 25 weeks) 2. Diastolic BP (baseline and follow-up at 25 weeks) 3. Quality of life (EQ5D-5L; baseline and follow-up at 25 weeks) 4. Side effects (baseline and follow-up at 25 weeks) 5. Participant preference for a single pill (baseline, 2 weeks and follow-up at 25 weeks) 6. Subjective and objective measures of adherence (MARS, NINA, attitudes towards medication, BMQ; baseline, 2 weeks and follow-up at 25 weeks) 7. Lifestyle measures (diet, physical activity [GPPAQ], smoking and alcohol; baseline and follow-up at 25 weeks) 8. Stroke, TIA, myocardial infarction, cardiovascular events, cardiovascular deaths, all-cause mortality and any hospital admissions possibly associated with AEs of Trinomia (follow-up at 25 weeks) 9. Costs (follow-up at 25 weeks) Previous secondary outcome measures: To determine: 1. Whether taking the 'polypill' is associated with higher adherence and/or false reassurance in people with a history of stroke/TIA (pill count, single item adherence measure, MARS, NINA, BMQ). 2. The cost effectiveness of a 'polypill' strategy for secondary prevention of stroke as compared to standard practice (participant characteristics [age, gender, existing condition], type and dose of medication, adherence, resource use, EuroQol EQ-5D). 3. Non-inferiority of the 'polypill' for the following measurements: LDL cholesterol; HDL cholesterol; total cholesterol; triglycerides; change in diastolic blood pressure; quality of life (EuroQol EQ-5D); side effects; participant and carer preference for treatment; major cardiovascular events, strokes, myocardial infarction and all-cause mortality. | — |
Countries
United Kingdom
Contacts
Public ContactMerel Pannebakker
Outcome results
None listed