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NCT03734640

Optimal Post Tpa-Iv Monitoring in Ischemic Stroke

Completed NA Last updated 26 March 2025
What this trial tests

NA trial testing Low-intensity monitoring strategy in Acute Ischemic Stroke Patients Receiving Reperfusion Therapy in 4,922 participants. Completed in 23 January 2025.

Timeline
28 April 2021
Primary endpoint
1 December 2024
23 January 2025

Quick facts

Lead sponsorCraig Anderson
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingsingle
Primary purposesupportive care
Enrollment4,922
Start date28 April 2021
Primary completion1 December 2024
Estimated completion23 January 2025
Sites54 locations across Malaysia, Chile, United Kingdom, Mexico, Australia, China, United States

Drugs / interventions tested

Conditions studied

Sponsor

Craig Anderson

Who can join

18 and older, any sex, with Acute Ischemic Stroke Patients Receiving Reperfusion Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Anderson CS, Summers D, Ouyang M, Sui Y, et al · · 2025 · cited 7× · PMID 40412428 · DOI 10.1016/s0140-6736(25)00549-5
  2. Low-Intensity Monitoring After Stroke Thrombolysis During the COVID-19 Pandemic.
    Faigle R, Johnson B, Summers D, Khatri P, et al · · 2020 · cited 7× · PMID 32514708 · DOI 10.1007/s12028-020-00998-0
  3. Glyceryl trinitrate for treating hyperacute stroke: the Efficacy of Nitric Oxide in Stroke-2 (ENOS-2) feasibility randomised controlled trial
    Woodhouse LJ, Mhlanga I, Buck A, Gray L, et al · · 2025 · cited 1× · DOI 10.21203/rs.3.rs-7494203/v1
  4. Statistical Analysis Plan for the Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMIST)
    Billot L, Bompoint S, Ouyang M, Xu L, et al · · 2024 · cited 1× · DOI 10.1101/2024.12.17.24319094
  5. Low-Intensity Monitoring for Mild-to-Moderate Acute Ischemic Stroke Is Cost Saving: Economic Evaluation for OPTIMISTmain.
    Xu L, Ouyang M, Atkins ER, Summers D, et al · · 2026 · PMID 41608808 · DOI 10.1161/strokeaha.125.053506

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