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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/NCT03734640
Registration number
NCT03734640
Ethics application status
Date submitted
6/11/2018
Date registered
8/11/2018
Date last updated
15/08/2023
Titles & IDs
Public title
Optimal Post Tpa-Iv Monitoring in Ischemic Stroke
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Scientific title
Optimal Post Tpa-Iv Monitoring in Ischemic Stroke
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Secondary ID [1]
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OPTIMISTmain
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke Patients Receiving Reperfusion Therapy
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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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Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Low-intensity monitoring strategy
Other interventions - Guideline recommended standard monitoring
Placebo Comparator: Guideline recommended standard monitoring - vital signs (HR, BP) and neurological assessment (GCS and NIHSS) 15-30mins x 2 hours, 30mins x 6 hours, 1hourly x 16 hours in usual care monitoring environment
Active Comparator: Low-intensity monitoring strategy - vital signs (HR, BP) and neurological assessment (GCS and/or NIHSS) 15-30mins x 2 hours, 2hourly x 8 hours, 4hourly x 14 hours in a non-ICU ward
Other interventions: Low-intensity monitoring strategy
Post-tpa patients will be monitored in a lower intensity with less vital status and neurological assessment
Other interventions: Guideline recommended standard monitoring
Post-tpa patients will be monitored in the usual care monitoring environment
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Intervention code [1]
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Other interventions
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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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modified Rankin scale (mRS); shift analysis across full range of scores
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Assessment method [1]
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Physical function measured according to a 7 level categorical scale, where 0-1 indicates no or minimal symptoms, 2-5 indicates increasing levels of disability/dependencey, and 6=death
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Timepoint [1]
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day 90
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Secondary outcome [1]
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frequency of major Symptomatic intracerebral hemorrhage
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Assessment method [1]
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intracerebral hemorrhage on brain imaging associated with significant neurological deterioration or death over 24 hours
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Timepoint [1]
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day 90
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Secondary outcome [2]
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Measures of hospital costs
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Assessment method [2]
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to allow economic analysis of treatment interventions at a country level
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Timepoint [2]
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day 90
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Secondary outcome [3]
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any serious adverse event during follow-up
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Assessment method [3]
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Timepoint [3]
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Within 90 days
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Eligibility
Key inclusion criteria
- adults (age =18 years);
- have received IV alteplase for AIS according to standard criteria;
- have a mild-moderate level of neurological impairment (e.g. score <10 on the NIHSS);
- stable and without any critical care needs at the end of the infusion of alteplase.
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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
- major neurological impairment;
- definite clinical contraindication or indication to either low-intensity or standard
neurological monitoring.
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Study design
Purpose of the study
Supportive Care
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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
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Intervention assignment
Other
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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
28/04/2021
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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
1/03/2025
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Actual
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Sample size
Target
7200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,WA
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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Concord Hospital - Concord
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Recruitment hospital [3]
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Nepean Hospital - Kingswood
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Recruitment hospital [4]
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St George Public Hospital - Kogarah
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Recruitment hospital [5]
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Prince of Wales Hospital - Randwick
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Royal North Shore Hospital - Sydney
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Recruitment hospital [7]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [8]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [9]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2065 - Canberra
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2747 - Kingswood
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Recruitment postcode(s) [4]
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2217 - Kogarah
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Recruitment postcode(s) [5]
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2031 - Randwick
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Recruitment postcode(s) [6]
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2050 - Sydney
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Recruitment postcode(s) [7]
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4102 - Brisbane
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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United States of America
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Maryland
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Massachusetts
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Ohio
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Oklahoma
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Chile
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Osorno
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Chile
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Valparaíso
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China
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Shenyang
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Malaysia
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Kota Bharu
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Malaysia
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Kuala Lumpur
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Serdang
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Ciudad de Mexico
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Mexico
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Puebla
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Cambridge
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Chester
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Exeter
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Nottingham
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Oxford
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United Kingdom
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Peterborough
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Funding & Sponsors
Primary sponsor type
Other
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Name
Craig Anderson
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Genentech, Inc.
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Johns Hopkins University
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Other collaborator category [3]
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Other
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Name [3]
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The George Institute for Global Health, Australia
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Address [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
OPTIMISTmain is an investigator-initiated and conducted, international, multicentre, stepped
wedge cluster randomized controlled trial comparing the effects of different intensities of
nursing care monitoring for patients with acute ischemic stroke of mild severity and without
critical care needs after IV-tPA.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03734640
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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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Craig S Anderson, MD PhD
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Address
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The George Institute
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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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Craig Anderson, PhD
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Address
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Country
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Phone
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+61 410476311
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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/NCT03734640
Download to PDF