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

Qualifiers

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

Treatments tested in this trial

  • anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration
  • Standard of Care Blood Pressure Management with Antihypertensives

Treatment groups

142 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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