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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03734640




Registration number
NCT03734640
Ethics application status
Date submitted
6/11/2018
Date registered
8/11/2018
Date last updated
2/07/2020

Titles & IDs
Public title
Optimal Post Tpa-Iv Monitoring in Ischemic Stroke
Scientific title
Optimal Post Tpa-Iv Monitoring in Ischemic Stroke
Secondary ID [1] 0 0
OPTIMISTmain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke Patients Receiving Reperfusion Therapy 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
modified Rankin scale (mRS); shift analysis across full range of scores - 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
Timepoint [1] 0 0
day 90
Secondary outcome [1] 0 0
frequency of major Symptomatic intracerebral hemorrhage - intracerebral hemorrhage on brain imaging associated with significant neurological deterioration or death over 24 hours
Timepoint [1] 0 0
day 90
Secondary outcome [2] 0 0
Measures of hospital costs - to allow economic analysis of treatment interventions at a country level
Timepoint [2] 0 0
day 90
Secondary outcome [3] 0 0
any serious adverse event during follow-up
Timepoint [3] 0 0
Within 90 days

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- major neurological impairment;

- definite clinical contraindication or indication to either low-intensity or standard
neurological monitoring.

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Craig Anderson
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Johns Hopkins University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The George Institute for Global Health, Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03734640
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig S Anderson, MD PhD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Craig Anderson, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 410476311
Fax 0 0
Email 0 0
canderson@georgeinstitute.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03734640