Tests tenecteplase for stroke with unknown time of onset
Tests tenecteplase, a clot-dissolving drug, in adults with unknown-onset stroke.
Plain-language title generated from the registry record
Registry title: Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging
Key facts
- Where
- Baise City, Chongzuo, Guangzhou, Guigang, Laibin, Liuzhou, Nanning, Qinzhou, Xiamen, and Yulin, ChinaSee the 15 sites
- Phase
- Phase 3
Where in China
- Baise People's HospitalBaise City, ChinaNot yet recruiting
- The People's Hospital of ChongzuoChongzuo, ChinaTaking people
- Guangzhou Twelfth People's HospitalGuangzhou, ChinaNot yet recruiting
- Guiping People's HospitalGuigang, ChinaNot yet recruiting
- People's Hospital of Qintang District, Guigang CityGuigang, ChinaNot yet recruiting
- Wuxuan County People's HospitalLaibin, ChinaNot yet recruiting
- Liuzhou Workers HospitalLiuzhou, ChinaNot yet recruiting
- Guangxi Medical University Kaiyuan Langdong HospitalNanning, ChinaNot yet recruiting
- Nanning Yongning District People's HospitalNanning, ChinaNot yet recruiting
- No.9 People's Hospital of NanningNanning, ChinaNot yet recruiting
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaNot yet recruiting
- The Second People's Hospital of QinzhouQinzhou, ChinaNot yet recruiting
- Zhongshan Hospital of Xiamen UniversityXiamen, ChinaNot yet recruiting
- Dingbian County People's HospitalYulin, ChinaNot yet recruiting
- Mizhi County HospitalYulin, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Guangxi Medical University
- Trial code
- NCT07475949
- Record updated
- 30 September 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥ 18 years old; Clinical diagnosis of acute ischemic stroke; Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time >4.5 hours; Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours; National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive); Pre-stroke modified Rankin Scale (mRS) score of 0-1; Written informed consent from patients or their legally authorized representatives.
Exclusion: Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months; Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage; Allergy to tenecteplase; Gastrointestinal or urinary tract hemorrhage in the past 3 weeks; Active internal bleeding; 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); 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; Platelet count <100×10\^9/L; Blood glucose <50 or >400 mg/dL (<2.78 or >22.2 mmol/L); Planned endovascular treatment; Rapid neurological improvement with NIHSS <6 at randomization; Hypodensity on non-contrast CT >1/3 middle cerebral artery territory; Severe traumatic brain injury or other major trauma in the past 3 months; Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm); Aortic dissection; Infective endocarditis; Women who are pregnant or breastfeeding; Systolic blood presure >185 mmHg or diastolic blood presure >110 mmHg refractory to treatment; Life expectancy <3 months; Participating in other trials.