NCT07475949 Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging
| NCT ID | NCT07475949 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | First Affiliated Hospital of Guangxi Medical University |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2026-09-24 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 352 participants in total. It began in 2026-09-24 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Yuan Wu, MD, PhD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Guangxi Medical University
Frequently Asked Questions
Who can join the NCT07475949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07475949 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 352 participants.
Is NCT07475949 currently recruiting?
Yes, NCT07475949 is actively recruiting participants. Contact the research team at dongpan012@hotmail.com for enrollment information.
Where is the NCT07475949 trial being conducted?
This trial is being conducted at Xiamen, China, Guangzhou, China, Baise City, China, Chongzuo, China and 11 additional locations.
Who is sponsoring the NCT07475949 clinical trial?
NCT07475949 is sponsored by First Affiliated Hospital of Guangxi Medical University. The principal investigator is Yuan Wu, MD, PhD at First Affiliated Hospital of Guangxi Medical University. The trial plans to enroll 352 participants.
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