European Blood Pressure Intensive Control After Stroke

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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. However, the optimal target blood pressure after a person suffers a stroke is not known. This is a study designed to establish the feasibility of a larger clinical trial, the aim of which will be to find out if greater blood pressure lowering is safe and effective for patients who suffer a stroke.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College Dublin
• Collaborators: Attikon Hospital; Cork University Hospital; Hospital Universitario La Paz; HRB Stroke Trials Network Ireland; Mater Misericordiae University Hospital; National University of Ireland, Galway, Ireland; Newcastle University; St Vincent's University Hospital, Ireland; Tallaght University Hospital; Universitaire Ziekenhuizen Leuven; University Hospital Waterford; University of Calgary; University of Limerick; University of Oslo
• Treatments: Antihypertensive Agents

Criteria

Inclusion Criteria:

1. Age ≥40

2. Ischaemic stroke, proven by imaging (including transient ischaemic attack with imaging evidence of acute brain ischaemia

3. Living at home and independent (walking without the aid of another person, but may have some help for daily activities - equivalent to Rankin score 3 or less)

4. SBP≥130mmHg at entry (average of 2 measures, seated, after resting alone in office for 5 minutes)

5. Qualifying Stroke/TIA between 7 days and 1 year of randomization

6. Glomerular filtration rate (eGFR) greater than or equal to 50 ml/min/m2

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. Stroke/TIA due to cardio-embolism or other defined causes (eg. dissection, endocarditis, other specified)

2. Severe stenosis of large cranio-cervical artery (>70% stenosis of cervical carotid, vertebral, or Circle of Willis artery)

3. Medical history of primary intracerebral haemorrhage (asymptomatic cerebral microbleeds detected on brain MRI are not excluded)

4. SBP <110mmHg after 3 minutes of standing or other contra-indication to intensive SBP lowering in opinion of treating clinician* (eg. syncope or pre-syncope, recurrent falls)

5. Unlikely to comply with study procedures (home BP measures, follow-up visits) due to severe or fatal co-morbid illness (eg. dementia, active malignancy, severe frailty) or other factor (eg. inability to travel)

6. Women of child-bearing potential