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

Plain Language Summary

Simplified for easier understanding

This trial tests whether keeping blood pressure at a more aggressive (lower) target after a stroke or mini-stroke (TIA) reduces the risk of having another stroke compared to standard blood pressure control. **You may be eligible if...** - You are 40 or older - You had an ischemic stroke or high-risk TIA confirmed by brain scan (CT or MRI) - Your stroke occurred between 30 days and 1 year ago - You live at home and can walk without help from another person - Your blood pressure is 140 mmHg or higher at screening - Your kidneys are working reasonably well **You may NOT be eligible if...** - Your stroke was caused by bleeding in the brain, a clot from the heart, or a tear in an artery - You have severe narrowing of a major artery in the brain or neck (>70%) - Your blood pressure drops significantly when you stand up - You are pregnant or breastfeeding - You have dementia, advanced cancer, or severe frailty Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.