Tenecteplase after non-contrast CT for unknown-onset stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

UTOPIA is a multicenter, randomized trial that compares intravenous tenecteplase plus standard care to standard care alone in adults with acute ischemic stroke of unknown onset, screened by non-contrast CT. Participants are 18 or older, with moderate stroke severity (NIHSS 6-25), last known normal more than 4.5 hours ago, and eligible for randomization within 3 hours of symptom recognition. The primary outcome is functional independence (mRS 0-1) at 90 days; safety outcomes include intracranial hemorrhage and other adverse events. The trial uses an open-label treatment with blinded endpoint assessment (PROBE design). Tenecteplase is given at 0.25 mg/kg up to 25 mg, in addition to standard medical treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.
2. Planned endovascular treatment.
3. Rapid neurological improvement with NIHSS \<6 at randomization.
4. Allergy to tenecteplase.
5. 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.
6. Hypodensity on non-contrast CT \>1/3 middle cerebral artery territory.
7. Severe traumatic brain injury or other major trauma in the past 3 months.
8. Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm).
9. Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months.
10. Gastrointestinal or urinary tract hemorrhage in the past 3 weeks.
11. Active internal bleeding.
12. Aortic dissection.
13. Infective endocarditis.
14. Platelet count \<100×10\^9/L.
15. Women who are pregnant or breastfeeding.
16. Blood glucose \<50 or \>400 mg/dL (\<2.78 or \>22.2 mmol/L).
17. Systolic blood presure \>185 mmHg or diastolic blood presure \>110 mmHg refractory to treatment.
18. Life expectancy \<3 months.
19. Participating in other trials.
20. 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).

Where it's running

• The People's Hospital of Chongzuo
  Chongzuo, Guangxi, China Recruiting
• Zhongshan Hospital of Xiamen University
  Xiamen, Fujian, China Not yet recruiting
• Guangzhou Twelfth People's Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• Baise People's Hospital
  Baise City, Guangxi, China Not yet recruiting
• People's Hospital of Qintang District, Guigang City
  Guigang, Guangxi, China Not yet recruiting
• Guiping People's Hospital
  Guigang, Guangxi, China Not yet recruiting

Study contacts

• Principal investigator: Yuan Wu, MD, PhD — First Affiliated Hospital of Guangxi Medical University
• Study coordinator: Dong Pan, MD, PhD
• Email: dongpan012@hotmail.com
• Phone: 86-156 2648 3251

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intravenous Tenecteplase in Very Old Adults with Acute Ischemic Stroke

  This study tests whether giving tenecteplase through a vein within 4.5 hours of stroke onset helps people 80 and older.

  Recruiting First Affiliated Hospital of Guangxi Medical University · Nanning, Guangxi · NCT07475936

• Short-Term outside-in nerve stimulation for acute ischemic stroke

  This trial tests whether a 5-day external trigeminal nerve stimulation given after stroke can help more patients recover better than a sham treatment.

  Recruiting Xidian University · Xi'an · NCT07911605

• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

  This study tests whether sevoflurane or propofol used for anesthesia during endovascular treatment of an acute ischemic stroke affects the final brain damage and recovery.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

• Safety of adding NRICM301 to standard care for adults with acute ischemic stroke

  This study tests whether adding NRICM301, a traditional Chinese medicine formula, to usual care is safe for adults with acute ischemic stroke.

  Recruiting En Chu Kong Hospital · New Taipei City · NCT07900503

• Intracranial Recanalization with LT3001 in Acute Ischemic Stroke

  This phase II study tests whether LT3001 given to adults with acute ischemic stroke can help reopen blocked brain arteries.

  Recruiting Phase 2 Lumosa Therapeutics Co., Ltd. · Taichung · NCT07890298

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

  Recruiting at 2 sites Karolinska Institutet · Tampere and 1 other locations · NCT07860333

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.