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Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

Study acronym: UTOPIA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Trial sites expanded: 1 → 15 locations
    • Start date changed from estimate of Sep 2026 to Sep 24, 2026
    • Interventions: Standard medical treatment (Other), Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) (Drug) to Standard medical treatment (Other), Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) (Drug)
    • Eligibility criteria shortened, about 3 words
  2. Start date: Apr 2026 to Sep 2026
    • Eligibility criteria expanded, about 3 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.
Trial Details
NCT Number NCT07475949
Lead Sponsor First Affiliated Hospital of Guangxi Medical University
Conditions
(from sponsor)		 Acute Ischemic Stroke, Tenecteplase
Related terms Ischemic Stroke
Enrollment 352 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov