Ischemic StrokePhase 2EPICS-PilotNCT04647292
European Blood Pressure Intensive Control After Stroke
A Phase 2 study testing anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration in people with Ischemic Stroke and Transient Ischemic Attack, run by University College Dublin at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteIreland
- Study dates
- 2 May 2024to Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Mater Misericordiae University Hospital
Dublin
Katrina Tobin, +353 1 716 4576, katrina.tobin@ucd.ie
Peter Kelly
About this study
Official title: European Blood Pressure Intensive Control After Stroke - Pilot 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.
Read the detailed description
Background:
Stroke is the third leading cause of global death, the leading cause of acquired disability and contributes substantially to dementia, cognitive decline, and healthcare costs. Global epidemiological studies such as INTERSTROKE and the Global Burden of Disease study estimated that hypertension is the leading modifiable risk factor for stroke, with a population attributable risk of approximately 50%. Recurrent vascular events (stroke, coronary events, vascular death) cause significant morbidity in ischaemic stroke survivors, affecting approximately 30% at 5 years.
High rates of failure to achieve guideline BP targets (<130mmHg) are reported in clinical practice for patients following ischaemic stroke or TIA. Home blood pressure measurement and telemonitoring is recognised as acceptable to patients from previous studies, and some trials have noted a significant reduction in BP at 12 months. The latest ESO guidelines note continued uncertainty over the use of out-of-office blood pressure measurements for adult patients with ischaemic stroke or TIA due to insufficient data.
This trial will recruit patients with recent stroke/TIA events with systolic BP ≥140 mmHg and randomise them to standard of care or home BP monitoring with telemonitoring and medication titration. 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.
Aim:
The aim is to conduct an initial pilot randomised trial in Ireland and European centres involved in the European Stroke Organisation Trials Alliance. This feasibility study will assess key design aspects and establish trial governance, data management, and procedures in preparation for a larger definitive trial.
Methods:
Design: Prospective, open-label, blinded endpoint assessed (PROBE) randomised, parallel group pilot/feasibility clinical trial, comparing BP patient self-measurement and telemonitoring with office-based monitoring (standard of care) for improved BP control after ischaemic stroke/TIA.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration, Standard of Care Blood Pressure Management with Antihypertensives
- Keywords
- ischemic stroke, transient ischemic attack, blood pressure, hypertension, recurrence, prognosis, prevention, randomized control trial, myocardial infarction, vascular events
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Hypertension, Recurrence, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-hypertensive, home blood pressure measurement, telemonitoring and medication titrationOther
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.
Standard of Care Blood Pressure Management with AntihypertensivesOther
Participants in the standard of care arm will receive antihypertensive therapy at the physician's discretion to the same treatment target of SBP <130mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Home Blood Pressure Measurement, Telemonitoring and Medication titration | Experimental | Medication titration to guideline SBP <130mmHg Receives: 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 Receives: Other: Standard of Care Blood Pressure Management with Antihypertensives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean SBP
The difference in mean SBP between both groups, at 12 months (or last trial visit)
Measured: 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
Measured: 12 months (or last trial visit)
Time in guideline-based target range
Proportion of SBP measures <130 during trial participation
Measured: 12 months (or last trial visit)
Time taken to reach target
Time taken to reach target SBP<130mmHg
Measured: 12 months (or last trial visit)
Difference in mean diastolic blood pressure (DBP) between groups
Measured: 12 months (or last trial visit)
Change in SBP/DBP from baseline to end-of-trial
Measured: 12 months (or last trial visit)
Time to first composite major adverse cardiovascular event (MACE), and to each component of the composite, stratified as fatal, non-fatal and total
MACE defined as all recurrent stroke, myocardial infarction, cardiac arrest
Measured: 12 months (or last trial visit)
All-cause fatality
Measured: 12 months (or last trial visit)
Comparison of disability in each intervention arm assessed by modified Rankin score
Shift analysis and proportion with no, mild, or moderate disability, Rankin score 0-3
Measured: 12 months (or last trial visit)
Number of dose-titrations required
Measured: 12 months (or last trial visit)
Time required per follow up visit
Measured: 12 months (or last trial visit)
Number of patients lost to follow-up
Measured: 12 months (or end of trial visit)
Number of serious adverse events
Difference in proportion of patients with serious adverse events
Measured: 12 months (or last trial visit)
Number of pre-specified adverse events
Measured: 12 months (or last trial visit)
Change in health related quality of life
Change in EQ5D-5L score (5 domains assessed with scores of 1-5 ranking the severity of impairment, with higher scores indicating poorer quality of life) at last follow-up compared with baseline
Measured: 12 months (or last trial visit)
Change in cognition
Change in Montreal cognitive assessment score (range 0-30) at last follow-up compared with baseline score. A lower score indicates greater cognitive impairment.
Measured: 12 months (or last trial visit)
Qualitative patient feedback obtained via workshops and questionnaires
Measured: 12 months (or last trial visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start2 May 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- St Vincent's University Hospital, Ireland, Cork University Hospital, Tallaght University Hospital, HRB Stroke Trials Network Ireland, National University of Ireland, Galway, Ireland, Mater Misericordiae University Hospital, St. James's Hospital, Ireland, Connolly Hospital Blanchardstown
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647292
- Sponsor's protocol ID
- 7580
- Acronym
- EPICS-Pilot
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2020
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are open to considering requests for collaborative projects.
Publications
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.
PubMed 36398903
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Blood Pressure Intensive Control After Stroke - Pilot Trial
- ClinicalTrials.gov ID
- NCT04647292
- Acronym / sponsor ID
- EPICS-Pilot / 7580
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- ischemic stroke, transient ischemic attack, blood pressure, hypertension, recurrence, prognosis, prevention, randomized control trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- St Vincent's University Hospital, Ireland, Cork University Hospital, Tallaght University Hospital, HRB Stroke Trials Network Ireland, National University of Ireland, Galway, Ireland, Mater Misericordiae University Hospital, St. James's Hospital, Ireland, Connolly Hospital Blanchardstown
- Study start
- 2 May 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Stroke is the third leading cause of global death, the leading cause of acquired disability and contributes substantially to dementia, cognitive decline, and healthcare costs. Global epidemiological studies such as INTERSTROKE and the Global Burden of Disease study estimated that hypertension is the leading modifiable risk factor for stroke, with a population attributable risk of approximately 50%. Recurrent vascular events (stroke, coronary events, vascular death) cause significant morbidity in ischaemic stroke survivors, affecting approximately 30% at 5 years.
High rates of failure to achieve guideline BP targets (<130mmHg) are reported in clinical practice for patients following ischaemic stroke or TIA. Home blood pressure measurement and telemonitoring is recognised as acceptable to patients from previous studies, and some trials have noted a significant reduction in BP at 12 months. The latest ESO guidelines note continued uncertainty over the use of out-of-office blood pressure measurements for adult patients with ischaemic stroke or TIA due to insufficient data.
This trial will recruit patients with recent stroke/TIA events with systolic BP ≥140 mmHg and randomise them to standard of care or home BP monitoring with telemonitoring and medication titration. 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.
Aim:
The aim is to conduct an initial pilot randomised trial in Ireland and European centres involved in the European Stroke Organisation Trials Alliance. This feasibility study will assess key design aspects and establish trial governance, data management, and procedures in preparation for a larger definitive trial.
Methods:
Design: Prospective, open-label, blinded endpoint assessed (PROBE) randomised, parallel group pilot/feasibility clinical trial, comparing BP patient self-measurement and telemonitoring with office-based monitoring (standard of care) for improved BP control after ischaemic stroke/TIA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Blood Pressure Measurement, Telemonitoring and Medication titration | Experimental | Other: anti-hypertensive, home blood pressure measurement, telemonitoring and medication titrationMedication titration to guideline SBP <130mmHg |
| Control Group: Standard of Care Blood Pressure Management | Active comparator | Other: Standard of Care Blood Pressure Management with AntihypertensivesStandard of Care Management by GP/physician to SBP <130mmHg by current European Stroke Organisation, American Stroke Association and UK NICE guidelines |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-hypertensive, home blood pressure measurement, telemonitoring and medication titrationA 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 | Home Blood Pressure Measurement, Telemonitoring and Medication titration |
| Standard of Care Blood Pressure Management with AntihypertensivesParticipants in the standard of care arm will receive antihypertensive therapy at the physician's discretion to the same treatment target of SBP <130mmHg. | Other | Control Group: Standard of Care Blood Pressure Management |
Primary outcome
Difference in mean SBP
Time frame: 12 months (or last trial visit)
The difference in mean SBP between both groups, at 12 months (or last trial visit)
16 secondary outcomes
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)
Time in guideline-based target range
Time frame: 12 months (or last trial visit)
Time taken to reach target
Time frame: 12 months (or last trial visit)
Difference in mean diastolic blood pressure (DBP) between groups
Time frame: 12 months (or last trial visit)
Change in SBP/DBP from baseline to end-of-trial
Time frame: 12 months (or last trial visit)
Time to first composite major adverse cardiovascular event (MACE), and to each component of the composite, stratified as fatal, non-fatal and total
Time frame: 12 months (or last trial visit)
All-cause fatality
Time frame: 12 months (or last trial visit)
Comparison of disability in each intervention arm assessed by modified Rankin score
Time frame: 12 months (or last trial visit)
Number of dose-titrations required
Time frame: 12 months (or last trial visit)
Time required per follow up visit
Time frame: 12 months (or last trial visit)
Number of patients lost to follow-up
Time frame: 12 months (or end of trial visit)
Number of serious adverse events
Time frame: 12 months (or last trial visit)
Number of pre-specified adverse events
Time frame: 12 months (or last trial visit)
Change in health related quality of life
Time frame: 12 months (or last trial visit)
Change in cognition
Time frame: 12 months (or last trial visit)
Qualitative patient feedback obtained via workshops and questionnaires
Time frame: 12 months (or last trial visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 36398903Saiz 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.
- Individual participant dataSharing planned: Undecided. The investigators are open to considering requests for collaborative projects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-hypertensive, home blood pressure measurement, telemonitoring and medication titration in people with Ischemic Stroke and Transient Ischemic Attack, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrina Tobin (+353 1 716 4576, katrina.tobin@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean SBP (time frame: 12 months (or last trial visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.