European Blood Pressure Intensive Control After Stroke

NCT04647292 | Recruiting Phase 2 DMC

• 1 other identifier: 7580
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ischemic stroke; transient ischemic attack; blood pressure; hypertension; recurrence; prognosis; prevention; randomized control trial; myocardial infarction; vascular events

Outcome Measures

Primary Outcomes (1)

• Difference in mean SBP

  The difference in mean SBP between both groups, at 12 months (or last trial visit)

  12 months (or last trial visit)

Secondary Outcomes (16)

• Proportions of patients assigned to each arm successfully reaching guideline-based target (SBP<130mmHg) at end of trial visit

  12 months (or last trial visit)

• Time in guideline-based target range

  12 months (or last trial visit)

• Time taken to reach target

  12 months (or last trial visit)

• Difference in mean diastolic blood pressure (DBP) between groups

  12 months (or last trial visit)

• Change in SBP/DBP from baseline to end-of-trial

  12 months (or last trial visit)

Other Outcomes (6)

• Number of patients who do not complete the study due to tolerability or other issues

  12 months (or end of trial visit)

• Ability of sites to rapidly identify eligible patients from clinics and stroke units

  12 months (or end of trial visit)

• Feasibility of home blood pressure (BP) measures and telemonitoring

  12 months (or end of trial visit)

Study Arms (2)

Home Blood Pressure Measurement, Telemonitoring and Medication titration

EXPERIMENTAL

Medication titration to guideline SBP \<130mmHg

Other: anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration

Control Group: Standard of Care Blood Pressure Management

ACTIVE COMPARATOR

Standard of Care Management by GP/physician to SBP \<130mmHg by current European Stroke Organisation, American Stroke Association and UK NICE guidelines

Other: Standard of Care Blood Pressure Management with Antihypertensives

Interventions

anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration OTHER

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.

Home Blood Pressure Measurement, Telemonitoring and Medication titration

Standard of Care Blood Pressure Management with Antihypertensives OTHER

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

Control Group: Standard of Care Blood Pressure Management

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• 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

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Ireland

RECRUITING

Related Publications (1)

• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.

  PMID: 36398903 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Hypertension; Recurrence; Myocardial Infarction

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Katrina Tobin

CONTACT

+353 1 716 4576; katrina.tobin@ucd.ie

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 30, 2020
• Study Start: May 2, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

IE (1)