European Blood Pressure Intensive Control After Stroke (NCT04647292) | Clinical Trial Compass
RecruitingPhase 2
European Blood Pressure Intensive Control After Stroke
Ireland142 participantsStarted 2024-05-02
Plain-language summary
Stroke is the third most common cause of death worldwide and the leading cause of disability. High blood pressure is an important risk factor for stroke. Lowering a person's blood pressure reduces the risk of future stroke or heart attack, and current guidelines recommend treatment to a target of \<130mmHg for secondary prevention.
Home blood pressure measurement and telemonitoring are acceptable to patients, but there is uncertainty over the use of out of office blood pressure measurements in stroke patients in guidelines.
This is a study designed to establish the feasibility of a larger clinical trial, comparing home blood pressure monitoring, telemonitoring and medication titration with standard care. The study hypothesis is that home BP measurement and telemonitoring with medication titration may lead to improved BP control compared to standard of care clinical practice.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Age ≥40
✓. Ischaemic stroke1, high-risk TIA, proven by imaging (brain CT/MRI)
✓. Living at home and independent (walking without the aid of another person, but may have some help for daily activities)
✓. SBP≥140mmHg at entry (average of 2 measures, seated, in the same arm, after resting alone in office for 10 minutes)
✓. Qualifying event between 30 days and 1 year of randomisation
✓. Glomerular filtration rate (eGFR) greater than or equal to 50ml/min/m2 (within 3 months of randomisation)
✓. Medically-stable and capable of participating in a randomised trial, including home BP measures, in the opinion of the study physician
✓. Willing to provide informed consent (no surrogate consent will apply)
Exclusion criteria
✕. SBP \<110mmHg after 3 minutes of standing or other contra-indication to intensive SBP lowering in opinion of treating clinician (eg. Orthostatic symptoms, syncope or pre syncope, recurrent falls)
✕. Qualifying stroke due to intracerebral haemorrhage (ICH), cardio-embolism or other defined causes (eg. dissection, endocarditis, other specified)
✕. Severe stenosis or occlusion of large cranio-cervical artery (\>70% stenosis/occlusion of cervical carotid, vertebral, or Circle of Willis artery)
✕. Unlikely to comply with study procedures due to severe or fatal comorbid illness (eg. dementia, active malignancy, severe frailty) or other factor (eg. inability to travel)