European Blood Pressure Intensive Control After Stroke
NCT04647292 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142
Last updated 2024-07-11
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.
Conditions
- Ischemic Stroke
- Transient Ischemic Attack
Interventions
- OTHER
-
anti-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.
- OTHER
-
Standard 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.
Sponsors & Collaborators
-
St Vincent's University Hospital, Ireland
collaborator OTHER -
Cork University Hospital
collaborator OTHER -
Tallaght University Hospital
collaborator OTHER -
HRB Stroke Trials Network Ireland
collaborator UNKNOWN -
National University of Ireland, Galway, Ireland
collaborator OTHER -
Mater Misericordiae University Hospital
collaborator OTHER -
St. James's Hospital, Ireland
collaborator OTHER -
Connolly Hospital Blanchardstown
collaborator OTHER -
University College Dublin
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-02
- Primary Completion
- 2025-12-31
- Completion
- 2026-03-31
Countries
- Ireland
Study Locations
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