European Blood Pressure Intensive Control After Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity College Dublin
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration
Other interventionA 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.
Standard of Care Blood Pressure Management with Antihypertensives
Other interventionParticipants in the standard of care arm will receive antihypertensive therapy at the physician's discretion to the same treatment target of SBP \<130mmHg.
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Home Blood Pressure Measurement, Telemonitoring and Medication titrationExperimental treatment 1 intervention
Group B: Control Group: Standard of Care Blood Pressure ManagementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in mean SBP
The difference in mean SBP between both groups, at 12 months (or last trial visit)
Time frame
12 months (or last trial visit)Secondary outcomes
1
Proportions of patients assigned to each arm successfully reaching guideline-based target (SBP<130mmHg) at end of trial visit
Time frame
12 months (or last trial visit)2
Time in guideline-based target range
Proportion of SBP measures \<130 during trial participation
Time frame
12 months (or last trial visit)3
Time taken to reach target
Time taken to reach target SBP\<130mmHg
Time frame
12 months (or last trial visit)4
Difference in mean diastolic blood pressure (DBP) between groups
Time frame
12 months (or last trial visit)Other outcomes
1
Number of patients who do not complete the study due to tolerability or other issues
Patients who are not retained in the study will give an insight into anticipated retention in the Phase 3 trial and sample size considerations.
Time frame
12 months (or end of trial visit)2
Ability of sites to rapidly identify eligible patients from clinics and stroke units
The inclusion of prevalent cases already attending stroke clinics or discharged from stroke units within the last year is an important design feature, aimed to rapidly accrue patients into the trial and thus to maximise the duration of follow-up within the terms allowed by funders. This outcome will be judged on the basis of qualitative feedback from participating sites.
Time frame
12 months (or end of trial visit)3
Feasibility of home blood pressure (BP) measures and telemonitoring
This outcome will be judged on the basis of qualitative feedback from participants and the the proportions of participants adhering to the use of home blood pressure diaries.
Time frame
12 months (or end of trial visit)4
Compliance with telemonitoring and feasibility of remote (phone) visits
The feasibility of remote (phone) visits will be assessed by the proportion of patients adhering to participation in remote visit consultations
Time frame
12 months (or end of trial visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University College Dublin
Lead sponsor
St Vincent's University Hospital, Ireland
Collaborator
Cork University Hospital
Collaborator
Tallaght University Hospital
Collaborator
HRB Stroke Trials Network Ireland
Collaborator
National University of Ireland, Galway, Ireland
Collaborator
Mater Misericordiae University Hospital
Collaborator
St. James's Hospital, Ireland
Collaborator
Connolly Hospital Blanchardstown
Collaborator
Source ClinicalTrials.gov