A Phase 3 interventional study of Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment in Acute Ischemic Stroke and Tenecteplase, sponsored by First Affiliated Hospital of Guangxi Medical University. Recruiting at 15 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by First Affiliated Hospital of Guangxi Medical University · Phase 3, Interventional, and Treatment
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.
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 352 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →First Affiliated Hospital of Guangxi Medical University is the lead sponsor of 41 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Medical Treatment
Other: Standard medical treatment
Intravenous tenecteplase thrombolysis
Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) · Other: Standard medical treatment
Drug page: Tenecteplase
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.
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.
Excellent outcome
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
Time frame: 90 (±14) days
Level of disability
Ordinal shift analysis of the mRS with 5-6 merged at 90 days.
Time frame: 90 (±14) days
Functional independence
The proportion of mRS score of 0-2 at 90 days.
Time frame: 90 (±14) days
Early neurological improvement
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours.
Time frame: 24 (±12) hours
Change in stroke severity
The change of NIHSS score from baseline to 7 days or at discharge (whichever comes first)
Time frame: 7 (±1) days or at discharge
Quality of life measured by EQ-5D-5L
EQ-5D-5L scale score at 90 days.
Time frame: 90 (±14) days
Symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage within 36 hours from randomization (Heidelberg criteria)
Time frame: 24 (±12) hours
Any intracranial hemorrhage
Incidence of any intracranial hemorrhage within 36 hours from randomization (Heidelberg classification)
Time frame: 24 (±12) hours
Extracranial bleeding
Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from randomization
Time frame: 24 (±12) hours
Mortality
All cause death within 90 days.
Time frame: 90 days
Plan to share: Yes — Data supporting the findings of the study are available on reasonable request after approval of a proposal from the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tenecteplase
First Affiliated Hospital of Guangxi Medical University