Optimal Post Tpa-Iv Monitoring in Ischemic Stroke
1 other identifier
interventional
4,922
7 countries
54
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2018
CompletedFirst Posted
Study publicly available on registry
November 8, 2018
CompletedStudy Start
First participant enrolled
April 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2025
CompletedMarch 26, 2025
March 1, 2025
3.6 years
November 6, 2018
March 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
day 90
Secondary Outcomes (3)
frequency of major Symptomatic intracerebral hemorrhage
day 90
Measures of hospital costs
day 90
any serious adverse event during follow-up
Within 90 days
Study Arms (2)
Guideline recommended standard monitoring
PLACEBO COMPARATORvital 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
Low-intensity monitoring strategy
ACTIVE COMPARATORvital 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
Interventions
Post-tpa patients will be monitored in a lower intensity with less vital status and neurological assessment
Post-tpa patients will be monitored in the usual care monitoring environment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- major neurological impairment;
- definite clinical contraindication or indication to either low-intensity or standard neurological monitoring.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Craig Andersonlead
- Genentech, Inc.collaborator
- Johns Hopkins Universitycollaborator
- The George Institute for Global Health, Australiacollaborator
Study Sites (54)
Centura St. Anthony Hospital
Lakewood, Colorado, 80228, United States
Centura Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
The John Hopkins Hospital
Baltimore, Maryland, 21287, United States
Howard County General Hospital
Columbia, Maryland, 21044, United States
University of Massachusetts Worcester
Worcester, Massachusetts, 01601, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Ascension Providence Hospital
Novi, Michigan, 48374, United States
SSM Health DePaul Hospital
Bridgeton, Missouri, 63044, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Renown Health
Reno, Nevada, 89502, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Cone Health
Greensboro, North Carolina, 27401, United States
OhioHealth Research Institute - Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
INTEGRIS Southwest Medical Center
Oklahoma City, Oklahoma, 73109, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Penn State Health
Hershey, Pennsylvania, 17033, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
ThedaCare Regional Medical Center Appleton
Appleton, Wisconsin, 54911, United States
Canberra Hospital
Canberra, Australian Capital Territory, 2065, Australia
Concord Hospital
Concord, New South Wales, 2139, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
St George Public Hospital
Kogarah, New South Wales, 2217, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2050, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Hospital de Puerto Montt
Port Montt, Los Lagos Region, Chile
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile
Hospital del Pino
Santiago, Santiago Metropolitan, Chile
Hospital La Florida Dra. Eloisa Díaz
Santiago, Santiago Metropolitan, Chile
Hospital Padre Hurtado
Santiago, Santiago Metropolitan, Chile
Hospital Sótero del Rio
Santiago, Santiago Metropolitan, Chile
Hospital Base de Osorno
Osorno, 5290000, Chile
Hospital Carlos Van Buren
Valparaíso, 2352499, Chile
Shenyang First People's Hospital
Shenyang, China
Hospital Universiti Sains Malaysia
Kota Bharu, 16150, Malaysia
Universiti Kebangssan Malaysia Medical Center
Kuala Lumpur, 56000, Malaysia
Hospital Pengajar Universiti Putra Malaysia (Hpupm)
Serdang, 43400, Malaysia
Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suarez
Mexico City, Mexico
Hospital Regional ISSSTE de Puebla
Puebla City, Mexico
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Countess of Chester Hospital
Chester, CH2 1UL, United Kingdom
Royal Devon and Exeter Hospital
Exeter, EX2 5DW, United Kingdom
Leicester Royal Infirmary
London, LE1 5WW, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
St George's University Hospitals
London, SW17 0QT, United Kingdom
Luton and Dunstable University Hospital
Luton, LU4 0DZ, United Kingdom
Nottingham University Hospitals
Nottingham, NG5 1PB, United Kingdom
Warnford Hospital
Oxford, OX3 9DU, United Kingdom
Peterborough City Hospital
Peterborough, PE3 9GZ, United Kingdom
Related Publications (2)
Xu L, Ouyang M, Atkins ER, Summers D, Sui Y, Johnson B, Billot L, Malavera A, Faigle R, Munoz-Venturelli P, Day D, Liu X, Li Q, Song L, Robinson TG, Gonzalez F, Urrutia-Goldsack F, Delcourt C, Nguyen HT, Ton MD, Liu H, Lindley RI, Arauz A, Mercado A, Wan Zaidi WA, Khatri P, Wang X, Urrutia VC, Jan S, Anderson CS. Low-Intensity Monitoring for Mild-to-Moderate Acute Ischemic Stroke Is Cost Saving: Economic Evaluation for OPTIMISTmain. Stroke. 2026 Jan 29. doi: 10.1161/STROKEAHA.125.053506. Online ahead of print.
PMID: 41608808DERIVEDAnderson CS, Summers D, Ouyang M, Sui Y, Johnson B, Billot L, Malavera A, Faigle R, Munoz-Venturelli P, Day D, Liu X, Li Q, Song L, Robinson TG, Gonzalez F, Urrutia-Goldsack F, Iacobelli M, Montalbano M, Pruski A, Delcourt C, Durham AC, Ebraimo A, Van Ta HH, Ghosh P, Leonhardt-Caprio A, Nguyen HT, Ton MD, Jan S, Liu H, Lindley RI, Arauz A, Mercado A, Zaidi WAW, Khatri P, Wang X, Urrutia VC; OPTIMISTmain Investigators. Safety and efficacy of low-intensity versus standard monitoring following intravenous thrombolytic treatment in patients with acute ischaemic stroke (OPTIMISTmain): an international, pragmatic, stepped-wedge, cluster-randomised, controlled non-inferiority trial. Lancet. 2025 May 31;405(10493):1909-1922. doi: 10.1016/S0140-6736(25)00549-5. Epub 2025 May 21.
PMID: 40412428DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Craig S Anderson, MD PhD
The George Institute
- PRINCIPAL INVESTIGATOR
Victor C Urrutia, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Guardian consent for intervention as standard of care service provision. Outcome assessed by independent researcher blind to treatment allocation
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Executive Director
Study Record Dates
First Submitted
November 6, 2018
First Posted
November 8, 2018
Study Start
April 28, 2021
Primary Completion
December 1, 2024
Study Completion
January 23, 2025
Last Updated
March 26, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 12 months after primary results publication
- Access Criteria
- Request with protocol to the Research Office of The George Institute
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