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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03734640
Ethics application status
Date submitted
6/11/2018
Date registered
8/11/2018

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
Timepoint [1] 0 0
day 90
Secondary outcome [1] 0 0
frequency of major Symptomatic intracerebral hemorrhage
Timepoint [1] 0 0
day 90
Secondary outcome [2] 0 0
Measures of hospital costs
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
Sex
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
Other
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
7200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
St George Public Hospital - Kogarah
Recruitment hospital [5] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [7] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - Canberra
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2050 - Sydney
Recruitment postcode(s) [7] 0 0
4102 - Brisbane
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Chile
State/province [14] 0 0
Los Lagos
Country [15] 0 0
Chile
State/province [15] 0 0
Región Metropolitana
Country [16] 0 0
Chile
State/province [16] 0 0
Osorno
Country [17] 0 0
Chile
State/province [17] 0 0
Valparaíso
Country [18] 0 0
China
State/province [18] 0 0
Shenyang
Country [19] 0 0
Malaysia
State/province [19] 0 0
Kota Bharu
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuala Lumpur
Country [21] 0 0
Malaysia
State/province [21] 0 0
Serdang
Country [22] 0 0
Mexico
State/province [22] 0 0
Ciudad de Mexico
Country [23] 0 0
Mexico
State/province [23] 0 0
Puebla
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Cambridge
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Chester
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Exeter
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Luton
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Nottingham
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Oxford
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Peterborough

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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
12 months after completion of the study, experienced researchers can seek a copy of the database through requests to the Research Office of The George Institute

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
12 months after primary results publication
Available to whom?
Request with protocol to the Research Office of The George Institute
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03734640