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Recruiting Phase 3

Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

NCT07475949 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-09-24
Last updated
2026-09-30

Condition(s) studied

Acute Ischemic StrokeTenecteplase

Investigational drug(s) / intervention(s)

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) →Standard medical treatment

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

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

Trial sites (15)

FacilityCityRegionStatus
Zhongshan Hospital of Xiamen University Xiamen Fujian Not Yet Recruiting
Guangzhou Twelfth People's Hospital Guangzhou Guangdong Not Yet Recruiting
Baise People's Hospital Baise City Guangxi Not Yet Recruiting
The People's Hospital of Chongzuo Chongzuo Guangxi Recruiting
People's Hospital of Qintang District, Guigang City Guigang Guangxi Not Yet Recruiting
Guiping People's Hospital Guigang Guangxi Not Yet Recruiting
Wuxuan County People's Hospital Laibin Guangxi Not Yet Recruiting
Liuzhou Workers' Hospital Liuzhou Guangxi Not Yet Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Not Yet Recruiting
Nanning Yongning District People's Hospital Nanning Guangxi Not Yet Recruiting
Guangxi Medical University Kaiyuan Langdong Hospital Nanning Guangxi Not Yet Recruiting
No.9 People's Hospital of Nanning Nanning Guangxi Not Yet Recruiting
The Second People's Hospital of Qinzhou Qinzhou Guangxi Not Yet Recruiting
Mizhi County Hospital Yulin Shaanxi Not Yet Recruiting
Dingbian County People's Hospital Yulin Shaanxi Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07475949 on ClinicalTrials.gov ↗ ← All trials in China