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Not yet recruiting NCT07475949

Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

Phase III Interventional Acute Ischemic Stroke Tenecteplase

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg), Standard medical treatment.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke, Tenecteplase. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Intravenous Tenecteplase for Acute Ischemic Stroke With Unknown Time of Onset Under Non-Contrast CT Selection: A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial

Overview

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.

Detailed description

UTOPIA is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) trial that aims to assess the efficacy and safety of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, selected by non-contrast CT. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days.

Participants randomized to the intervention group will receive intravenous tenecteplase at 0.25 mg/kg with a maximum dose of 25 mg and standard medical treatment, and those randomized to the control group will receive standard medical treatment only, without intravenous thrombolysis.

Interventions

  • Drug Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
    Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization.
  • Other Standard medical treatment
    Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.

Primary outcome measures

  • Excellent outcome [Time frame: 90 (±14) days]
Secondary outcome measures (5)
  • Level of disability [Time frame: 90 (±14) days]
  • Functional independence [Time frame: 90 (±14) days]
  • Early neurological improvement [Time frame: 24 (±12) hours]
  • Change in stroke severity [Time frame: 7 (±1) days or at discharge]
  • Quality of life measured by EQ-5D-5L [Time frame: 90 (±14) days]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old.
  • Clinical diagnosis of acute ischemic stroke.
  • Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time >4.5 hours.
  • Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours.
  • National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive).
  • Pre-stroke modified Rankin Scale (mRS) score of 0-1.
  • Written informed consent from patients or their legally authorized representatives.

Exclusion criteria

  • Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.
  • Rapid neurological improvement with NIHSS <6 at randomization.
  • Allergy to tenecteplase.
  • Use of vitamin K antagonist with INR >1.7, use of heparin or low molecular heparin in the past 24 hours, or use of direct oral anticoagulants in the past 48 hours.
  • Hypodensity on non-contrast CT >1/3 middle cerebral artery territory.
  • Severe traumatic brain injury or other major trauma in the past 3 months.
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm).
  • Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months.
  • Gastrointestinal or urinary tract hemorrhage in the past 3 weeks.
  • Active internal bleeding.
  • Aortic dissection.
  • Infective endocarditis.
  • Platelet count <100×10\^9/L.
  • Women who are pregnant or breastfeeding.
  • Blood glucose <50 or >400 mg/dL (<2.78 or >22.2 mmol/L).
  • Systolic blood presure >185 mmHg or diastolic blood presure >110 mmHg refractory to treatment.
  • Life expectancy <3 months.
  • Participating in other trials.
  • Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Guangxi Medical University — Nanning

Identifiers

NCT: NCT07475949 · 2026-K0007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗