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
- Conditions
- Stroke preventionCirculatory System
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1222
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measures as of 28/07/2015:<br>Systolic blood pressure at baseline and follow-up at 25 weeks<br><br>Previous primary outcome measures:<br>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 Outcome Measures
Name Time Method