Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

Starting soon · Phase 3

Conditions studied: Acute Ischemic Stroke, Tenecteplase

In brief

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.

Key facts

Study ID

NCT07475949

Run by

First Affiliated Hospital of Guangxi Medical University

People needed

352

Starts

2026-04-01

Expected to finish

2028-12-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.
• Rapid neurological improvement with NIHSS <6 at randomization.
• Allergy to tenecteplase.
• 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.
• 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).
• Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months.
• Gastrointestinal or urinary tract hemorrhage in the past 3 weeks.
• Active internal bleeding.
• Aortic dissection.
• Infective endocarditis.
• Platelet count <100×10\^9/L.
• Women who are pregnant or breastfeeding.
• Blood glucose <50 or >400 mg/dL (<2.78 or >22.2 mmol/L).
• Systolic blood presure >185 mmHg or diastolic blood presure >110 mmHg refractory to treatment.
• Life expectancy <3 months.
• Participating in other trials.
• 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).

Where it is running

• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China

Full record on ClinicalTrials.gov

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