StrokeMASTERSTROKENCT05645861
MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE
A study testing Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg in people with Stroke and Embolus Cerebral, run by Auckland City Hospital at 6 sites in 2 countries.
Trial summary
Stroke is the third most common cause of death in New Zealand and is one of the leading causes of long-term disability at all ages. A life-saving clot retrieval procedure can save lives and prevent disability of patients with ischaemic stroke who get to hospital in time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Embolus Cerebral, Blood Pressure
- What is being tested?
- Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 28 Nov 2019to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with anterior circulation stroke (ICA or proximal M1 or M2 segment of MCA) treated with ECR within 6 hrs of stroke onset and ECR patients presenting within 6-24 hours and favourable penumbra on perfusion scanning (see criteria 1-3).
- Additional criteria in the 6 to 24-hour window.
- 'wake up' stroke; CT with no (or at most minimal) acute infarction or
- patient 80 years or older (NIHSS of 10 and infarct volume less than 21 ml on DWI or CT perfusion-CBF)
- patient less than 80 years (NIHSS of 10 and infarct volume less than 31 ml on DWI or CT perfusion-CBF NIHSS of 20 and infarct volume less than 51 ml on DWI or CT perfusion-CBF).
Who cannot join
- Rescue"' procedures eg acute ischaemic stroke associated with major medical procedures such as coronary artery stenting and coronary artery bypass
- pre-stroke mRS>=3
- not having GA
- terminal illness with expected survival <1 year
- pregnancy
- cardiovascular conditions where BP targeting will be contra-indicated
- unable to participate in 3-month follow up
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia3 sites
Gold Coast University Hospital
Southport, Queensland, 4215
Royal North Shore Hospital
Sydney, New South Wales, 2065
Metro South Hospital and Health Service via the Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand3 sites
Auckland City Hopsital
Auckland, Auckland, 1023
Christchurch Hospital
Christchurch, Canterbury, 8140
Wellington Regional Hospital
Newton, Wellington Region, 6021
About this study
Official title: MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE: the MASTERSTROKE Trial
Stroke is the third most common cause of death in New Zealand and is one of the leading causes of long-term disability at all ages. A life-saving clot retrieval procedure can save lives and prevent disability of patients with ischaemic stroke who get to hospital in time. In New Zealand, 90% of clot retrieval procedures are performed under general anaesthesia. Many anaesthetic drugs can affect blood pressure (BP) and blood flow within the brain. Increasing BP during the procedure could provide additional benefits in this devastating disease. A large trial is needed to investigate BP management during clot retrieval.
Read the detailed description
Internationally stroke ranks second among all causes of disability and is adding to considerable worldwide healthcare burden. Over the last 5 years a new procedure to remove clots (Endovascular Thrombectomy - EVT) has been effective for the treatment of acute large strokes, with significant reductions in long term patient disability compared to standard treatment. However, there minimal guidance on blood pressure management during the procedure. The brain is especially vulnerable to low blood pressure during the acute stroke period due to low blood supply, impairment of how the brain regulates blood flow and further falls in blood flow to the brain. High blood pressure may be beneficial due to increased blood flow in areas at risk during this time. It could be harmful due to brain injury process, swelling, and bleeding into the brain. Conversely, relatively low blood pressure could be harmful. Current evidence is limited to large observational studies. This randomised controlled study will examine the safety and efficacy of two systolic blood pressures (SBP) management arms during general anaesthesia for EVT on outcomes in patients with acute ischaemic stroke.
- Conditions
- Stroke, Embolus Cerebral, Blood Pressure
- Being tested
- Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg
- Medical subject headings
- Stroke, Intracranial Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHgProcedure or surgery
Techniques used to target SBP will not be controlled for and will be at the discretion of the procedural anaesthetist to manage blood pressure, this can include vasopressors, intravenous fluids, titration of anaesthetic maintenance drugs and use of other vasoactive drugs.
| Study group | Role | What they receive |
|---|---|---|
| Augmented - Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHg | Active comparator | Techniques used to target SBP will not be controlled for and will be at the discretion of the procedural anaesthetist to manage blood pressure, this can include vasopressors, intravenous fluids, titration of anaesthetic maintenance drugs and use of other vasoactive drugs. Receives: Procedure: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg |
| Standard - Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg | Active comparator | Techniques used to target SBP will not be controlled for and will be at the discretion of the procedural anaesthetist to manage blood pressure, this can include vasopressors, intravenous fluids, titration of anaesthetic maintenance drugs and use of other vasoactive drugs. Receives: Procedure: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 90 Modified Rankin Score
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 (no symptoms at all) to 5 (severe disability). A separate category of 6 is usually added for patients who are deceased.
Measured: 90 days Post Thrombectomy
Secondary outcomes (5)
Independent functionality
Independent functional outcome as determined by a modified Rankin Score of 0,1,or 2 at 90 Days. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 (no symptoms at all) to 5 (severe disability). A separate category of 6 is usually added for patients who are deceased.
Measured: 90 days Post Thrombectomy
Days Alive out of Hospital (DAOH)
The number of days a participant spends at home in the first 90 days post-stroke (home days/DAH90 confirmed by patient follow-up and clinical note review.
Measured: 90 days Post Thrombectomy
All cause mortality
All cause mortality confirmed by patient follow-up and clinical note review.
Measured: 90 days Post Thrombectomy
Intraprocedural complications
Proportion of patients with intra-procedural complications (target vessel dissection, intracerebral haemorrhage, groin haematoma) as documented in medical records.
Measured: From randomisation until 36 hours post treatment
Complicaiton of importance - symptomatic intracranial haemorrhage
Proportion of patients with symptomatic intracranial haemorrhage (within 36 hours of treatment) as documented in medical records.
Measured: From randomisation until 36 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start28 Nov 2019
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auckland City Hospital
- Sponsor type
- Other government
- Collaborators
- Australian and New Zealand College of Anaesthetists, Neurological Foundation of New Zealand, The University of Queensland, Auckland Medical Research Foundation, Auckland Hospitals Research and Endowment Fund
- Responsible party
- Sponsor
- Investigators
- Doug Campbell, Dr, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645861
- Sponsor's protocol ID
- MasterStroke vs 1.4
- Other IDs
- 1920 PG, 22/001, A+ 8173, 2119013, ACTRN12619001274167
- Acronym
- MASTERSTROKE
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2022
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time the steering committee have not developed an IPD data sharing plan. Once the decision has been made regarding this process the information will be updated accordingly.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE: the MASTERSTROKE Trial
- ClinicalTrials.gov ID
- NCT05645861
- Acronym / sponsor ID
- MASTERSTROKE / MasterStroke vs 1.4
- Conditions
- Stroke, Embolus Cerebral, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Auckland City HospitalOther government
- Collaborators
- Australian and New Zealand College of Anaesthetists, Neurological Foundation of New Zealand, The University of Queensland, Auckland Medical Research Foundation, Auckland Hospitals Research and Endowment Fund
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Dec 2022 (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 in New Zealand and is one of the leading causes of long-term disability at all ages. A life-saving clot retrieval procedure can save lives and prevent disability of patients with ischaemic stroke who get to hospital in time. In New Zealand, 90% of clot retrieval procedures are performed under general anaesthesia. Many anaesthetic drugs can affect blood pressure (BP) and blood flow within the brain. Increasing BP during the procedure could provide additional benefits in this devastating disease. A large trial is needed to investigate BP management during clot retrieval.
Detailed description
Internationally stroke ranks second among all causes of disability and is adding to considerable worldwide healthcare burden. Over the last 5 years a new procedure to remove clots (Endovascular Thrombectomy - EVT) has been effective for the treatment of acute large strokes, with significant reductions in long term patient disability compared to standard treatment. However, there minimal guidance on blood pressure management during the procedure. The brain is especially vulnerable to low blood pressure during the acute stroke period due to low blood supply, impairment of how the brain regulates blood flow and further falls in blood flow to the brain. High blood pressure may be beneficial due to increased blood flow in areas at risk during this time. It could be harmful due to brain injury process, swelling, and bleeding into the brain. Conversely, relatively low blood pressure could be harmful. Current evidence is limited to large observational studies. This randomised controlled study will examine the safety and efficacy of two systolic blood pressures (SBP) management arms during general anaesthesia for EVT on outcomes in patients with acute ischaemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented - Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHg | Active comparator | Procedure: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHgTechniques used to target SBP will not be controlled for and will be at the discretion of the procedural anaesthetist to manage blood pressure, this can include vasopressors, intravenous fluids, titration of anaesthetic maintenance drugs and use of other vasoactive drugs. |
| Standard - Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg | Active comparator | Procedure: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHgTechniques used to target SBP will not be controlled for and will be at the discretion of the procedural anaesthetist to manage blood pressure, this can include vasopressors, intravenous fluids, titration of anaesthetic maintenance drugs and use of other vasoactive drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with anterior circulation stroke (ICA or proximal M1 or M2 segment of MCA) treated with ECR within 6 hrs of stroke onset and ECR patients presenting within 6-24 hours and favourable penumbra on perfusion scanning (see criteria 1-3).
- Additional criteria in the 6 to 24-hour window.
- 'wake up' stroke; CT with no (or at most minimal) acute infarction or
- patient 80 years or older (NIHSS of 10 and infarct volume less than 21 ml on DWI or CT perfusion-CBF)
- patient less than 80 years (NIHSS of 10 and infarct volume less than 31 ml on DWI or CT perfusion-CBF NIHSS of 20 and infarct volume less than 51 ml on DWI or CT perfusion-CBF).
Key exclusion criteria (7 listed)
- Rescue"' procedures eg acute ischaemic stroke associated with major medical procedures such as coronary artery stenting and coronary artery bypass
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 |
|---|---|---|
| Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHgTechniques used to target SBP will not be controlled for and will be at the discretion of the procedural anaesthetist to manage blood pressure, this can include vasopressors, intravenous fluids, titration of anaesthetic maintenance drugs and use of other vasoactive drugs. | Procedure or surgery | Augmented - Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHg, Standard - Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg |
Primary outcome
Day 90 Modified Rankin Score
Time frame: 90 days Post Thrombectomy
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 (no symptoms at all) to 5 (severe disability). A separate category of 6 is usually added for patients who are deceased.
5 secondary outcomes
Independent functionality
Time frame: 90 days Post Thrombectomy
Days Alive out of Hospital (DAOH)
Time frame: 90 days Post Thrombectomy
All cause mortality
Time frame: 90 days Post Thrombectomy
Intraprocedural complications
Time frame: From randomisation until 36 hours post treatment
Complicaiton of importance - symptomatic intracranial haemorrhage
Time frame: From randomisation until 36 hours post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Australia New Zealand College of Anaesthesia current researchLink provided by the sponsor.
- Individual participant dataSharing planned: No. At this time the steering committee have not developed an IPD data sharing plan. Once the decision has been made regarding this process the information will be updated accordingly.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Doug Campbell, Dr principal investigator
Auckland City Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg in people with Stroke and Embolus Cerebral, run by Auckland City Hospital at 6 sites in 2 countries.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, New Zealand. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 90 Modified Rankin Score (time frame: 90 days Post Thrombectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.