NCT04647292 European Blood Pressure Intensive Control After Stroke
| NCT ID | NCT04647292 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University College Dublin |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2024-05-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 142 participants in total. It began in 2024-05-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04647292 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04647292 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04647292 currently recruiting?
Yes, NCT04647292 is actively recruiting participants. Contact the research team at katrina.tobin@ucd.ie for enrollment information.
Where is the NCT04647292 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT04647292 clinical trial?
NCT04647292 is sponsored by University College Dublin. The trial plans to enroll 142 participants.
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