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NOT YET RECRUITING

NCT07475949

PHASE3

Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

Sponsor: First Affiliated Hospital of Guangxi Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2026-04

Completion Date

2028-12

Last Updated

2026-03-17

Healthy Volunteers

Conditions

Acute Ischemic Stroke Tenecteplase

Interventions

DRUG

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.

OTHER

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.

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

Locations (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China