RecruitingPhase 2NCT04647292

European Blood Pressure Intensive Control After Stroke

European Blood Pressure Intensive Control After Stroke - Pilot Trial

Sponsor

University College Dublin

Enrollment

142 participants

Start Date

May 2, 2024

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke Transient Ischemic Attack

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

Min Age: 40 Years

Inclusion Criteria8

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 Criteria5

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)
Pregnancy or breastfeeding

Interventions

OTHERanti-hypertensive, home blood pressure measurement, telemonitoring and medication titration

A medication algorithm based on the SPRINT trial protocol will be provided for patients in the home blood pressure measurement arm. The final choice and dose of antihypertensive treatment(s) will be at the discretion of the treating clinicians. If no contra-indications, indapamide or other thiazide diuretic and/or angiotensin-converting enzyme (ACE) inhibitor (perindopril or other) will be encouraged as initial therapy, with long-acting calcium-channel antagonists (eg.amlodipine) encouraged as third-line therapy. Patients will have their home blood pressure monitoring diary reviewed by the study team. If SBP is out of the allocated target range, a prescription to titrate antihypertensive medication will be sent to the patient at least monthly.

OTHERStandard of Care Blood Pressure Management with Antihypertensives

Participants in the standard of care arm will receive antihypertensive therapy at the physician's discretion to the same treatment target of SBP \<130mmHg.