Acute Ischemic StrokePhase 3UTOPIANCT07475949

Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

A Phase 3 study testing Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment in people with Acute Ischemic Stroke and Tenecteplase, run by First Affiliated Hospital of Guangxi Medical University at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Ischemic Stroke, Tenecteplase
What is being tested?: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and Standard medical treatment
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 352 participants
Where: 15 sitesChina
Study dates: 24 Sep 2026to Dec 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.
Planned endovascular treatment.
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.

Show all 20Show fewer

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).

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dong Pan, MD, PhD contact

86-156 2648 3251

dongpan012@hotmail.com

City, postcode or hospital

Sites recruiting now only

15 sites in 1 country

China15 sites, 15 recruiting

Baise People's Hospital
Baise City, Guangxi, 533000
Dengxing Li
Not yet recruiting
The People's Hospital of Chongzuo
Chongzuo, Guangxi, 532200
Jianyi Huang
Recruiting
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong, 510620
Jianwu Dai
Not yet recruiting
People's Hospital of Qintang District, Guigang City
Guigang, Guangxi, 537121
Jixin Lu
Not yet recruiting
Guiping People's Hospital
Guigang, Guangxi, 537200
Peiquan Yang
Not yet recruiting
Wuxuan County People's Hospital
Laibin, Guangxi, 545900
Yu Huang
Not yet recruiting
Liuzhou Workers' Hospital
Liuzhou, Guangxi, 545007
Liya Pan
Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Dong Pan, MD, PhD, 86-156 2648 3251, dongpan012@hotmail.com
Yuan Wu, MD, PhD
Not yet recruiting
Nanning Yongning District People's Hospital
Nanning, Guangxi, 530200
Wuqiao Liang
Qihai Zhou
Not yet recruiting
Guangxi Medical University Kaiyuan Langdong Hospital
Nanning, Guangxi, 530219
Kai Chen
Not yet recruiting
No.9 People's Hospital of Nanning
Nanning, Guangxi, 530409
Jun Qu
Not yet recruiting
The Second People's Hospital of Qinzhou
Qinzhou, Guangxi, 535000
Caixia Xuan
Not yet recruiting
Zhongshan Hospital of Xiamen University
Xiamen, Fujian, 361004
Xingyu Chen
Not yet recruiting
Mizhi County Hospital
Yulin, Shaanxi, 718100
Tao Zhang
Not yet recruiting
Dingbian County People's Hospital
Yulin, Shaanxi, 718600
Gaiyan Qu
Not yet recruiting

Other trials in China

About this study

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

Read the 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.

Conditions: Acute Ischemic Stroke, Tenecteplase
Being tested: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg), Standard medical treatment
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)Drug
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 treatmentOther
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.

Study groups in NCT07475949
Study group	Role	What they receive
Control group	Other	Standard Medical Treatment Receives: Other: Standard medical treatment
Tenecteplase group	Experimental	Intravenous tenecteplase thrombolysis Receives: Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg); Other: Standard medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Excellent outcome
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
Measured: 90 (±14) days

Secondary outcomes (5)

Level of disability
Ordinal shift analysis of the mRS with 5-6 merged at 90 days.
Measured: 90 (±14) days
Functional independence
The proportion of mRS score of 0-2 at 90 days.
Measured: 90 (±14) days
Early neurological improvement
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours.
Measured: 24 (±12) hours
Change in stroke severity
The change of NIHSS score from baseline to 7 days or at discharge (whichever comes first)
Measured: 7 (±1) days or at discharge
Quality of life measured by EQ-5D-5L
EQ-5D-5L scale score at 90 days.
Measured: 90 (±14) days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 2026Dec 2028

First posted17 Mar 2026
Study start24 Sep 2026
Primary completionDec 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 352 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07475949
Sponsor's protocol ID: 2026-K0237
Acronym: UTOPIA
Status last verified: Sep 2026
First submitted: 13 Mar 2026
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data supporting the findings of the study are available on reasonable request after approval of a proposal from the principal investigator.

Interested in taking part?

Dong Pan, MD, PhD

86-156 2648 3251

dongpan012@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Acute Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07475949
Acronym / sponsor ID: UTOPIA / 2026-K0237
Conditions: Acute Ischemic Stroke, Tenecteplase
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 352 participants (estimated)
Lead sponsor: First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
Study start: 24 Sep 2026 (actual)
Primary completion: Dec 2028 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 17 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control group	Other	Other: Standard medical treatmentStandard Medical Treatment
Tenecteplase group	Experimental	Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg), Other: Standard medical treatmentIntravenous tenecteplase thrombolysis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (20 listed)

Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.
Planned endovascular treatment.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Drug	Tenecteplase group
Standard medical treatmentStandard 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.	Other	Control group, Tenecteplase group

Primary outcome

Excellent outcome
Time frame: 90 (±14) days
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days

5 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Individual participant dataSharing planned: Yes. Data supporting the findings of the study are available on reasonable request after approval of a proposal from the principal investigator.

Related trials for Acute Ischemic Stroke

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
Not yet recruiting
Prehospital Response and Emergency Stroke Transport Optimisation
Acute Ischemic Stroke
RecruitingPhase 2
A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
Acute Ischemic Stroke
Active, not recruiting
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Dong Pan, MD, PhD contact

86-156 2648 3251

dongpan012@hotmail.com

Yuan Wu, MD, PhD principal investigator

First Affiliated Hospital of Guangxi Medical University

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong Pan, MD, PhD (86-156 2648 3251, dongpan012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excellent outcome (time frame: 90 (±14) days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07475949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.