Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT04647292
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥40
2. Ischaemic stroke1, high-risk TIA, proven by imaging (brain CT/MRI)
3. Living at home and independent (walking without the aid of another person, but may have some help for daily activities)
4. SBP≥140mmHg at entry (average of 2 measures, seated, in the same arm, after resting alone in office for 10 minutes)
5. Qualifying event between 30 days and 1 year of randomisation
6. Glomerular filtration rate (eGFR) greater than or equal to 50ml/min/m2 (within 3 months of randomisation)
7. Medically-stable and capable of participating in a randomised trial, including home BP measures, in the opinion of the study physician
8. Willing to provide informed consent (no surrogate consent will apply)
Exclusion Criteria:
1. 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)
2. Qualifying stroke due to intracerebral haemorrhage (ICH), cardio-embolism or other defined causes (eg. dissection, endocarditis, other specified)
3. Severe stenosis or occlusion of large cranio-cervical artery (\>70% stenosis/occlusion of cervical carotid, vertebral, or Circle of Willis artery)
4. 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)
5. Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04647292
Study Brief:
Protocol Section:
NCT04647292