RECRUITING
Phase 3
ClinicalTrials.gov
Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging
Sponsor: First Affiliated Hospital of Guangxi Medical University • ClinicalTrials.gov ID: NCT07475949
Registry updated: 2026-09-30
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Check Eligibility →Description
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.
Interventions
-
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 treatment
(Other)
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.
Eligibility criteria
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).
Conditions
Acute Ischemic Stroke
Tenecteplase
Locations
- Zhongshan Hospital of Xiamen University — Xiamen, Fujian, China
- Guangzhou Twelfth People's Hospital — Guangzhou, Guangdong, China
- Baise People's Hospital — Baise City, Guangxi, China
- The People's Hospital of Chongzuo — Chongzuo, Guangxi, China
- People's Hospital of Qintang District, Guigang City — Guigang, Guangxi, China
- Guiping People's Hospital — Guigang, Guangxi, China
- Wuxuan County People's Hospital — Laibin, Guangxi, China
- Liuzhou Workers' Hospital — Liuzhou, Guangxi, China
- The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
- Nanning Yongning District People's Hospital — Nanning, Guangxi, China
- Guangxi Medical University Kaiyuan Langdong Hospital — Nanning, Guangxi, China
- No.9 People's Hospital of Nanning — Nanning, Guangxi, China
- The Second People's Hospital of Qinzhou — Qinzhou, Guangxi, China
- Mizhi County Hospital — Yulin, Shaanxi, China
- Dingbian County People's Hospital — Yulin, Shaanxi, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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