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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05645861
Registration number
NCT05645861
Ethics application status
Date submitted
30/11/2022
Date registered
12/12/2022
Date last updated
15/02/2024
Titles & IDs
Public title
MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE
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Scientific title
MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE: the MASTERSTROKE Trial
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Secondary ID [1]
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ACTRN12619001274167
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Secondary ID [2]
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MasterStroke vs 1.3
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Universal Trial Number (UTN)
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Trial acronym
MASTERSTROKE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
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Embolus Cerebral
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Blood Pressure
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg
Active Comparator: Augmented - Systolic Blood Pressure (SBP) at 170mmHg +/- 10 mmHg - 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.
Active Comparator: Standard - Systolic Blood Pressure (SBP) at 140mmHg +/- 10 mmHg - 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.
Treatment: Surgery: Blood pressure management of Systolic Blood Pressure to maintain target range +/- 10 mmHg
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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Day 90 Modified Rankin Score
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Assessment method [1]
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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.
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Timepoint [1]
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90 days Post Thrombectomy
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Secondary outcome [1]
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Independent functionality
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Assessment method [1]
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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.
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Timepoint [1]
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90 days Post Thrombectomy
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Secondary outcome [2]
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Days Alive out of Hospital (DAOH)
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Assessment method [2]
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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.
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Timepoint [2]
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90 days Post Thrombectomy
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Secondary outcome [3]
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All cause mortality
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Assessment method [3]
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All cause mortality confirmed by patient follow-up and clinical note review.
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Timepoint [3]
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90 days Post Thrombectomy
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Secondary outcome [4]
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Intraprocedural complications
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Assessment method [4]
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Proportion of patients with intra-procedural complications (target vessel dissection, intracerebral haemorrhage, groin haematoma) as documented in medical records.
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Timepoint [4]
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From randomisation until 36 hours post treatment
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Secondary outcome [5]
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Complicaiton of importance - symptomatic intracranial haemorrhage
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Assessment method [5]
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Proportion of patients with symptomatic intracranial haemorrhage (within 36 hours of treatment) as documented in medical records.
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Timepoint [5]
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From randomisation until 36 hours post treatment
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Eligibility
Key inclusion criteria
- 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.
1. 'wake up' stroke; CT with no (or at most minimal) acute infarction or
2. patient 80 years or older (NIHSS of 10 and infarct volume less than 21 ml on DWI or CT
perfusion-CBF)
3. 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
550
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Canterbury
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Auckland City Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05645861
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Doug Campbell, Dr
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Address
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Auckland City Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Davina J McAllister
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Address
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Country
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Phone
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+6493757095
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05645861
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