Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging (NCT07475949) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging
China352 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Excellent outcome
Timeframe: 90 (±14) days
Trial details
NCT IDNCT07475949
SponsorFirst Affiliated Hospital of Guangxi Medical University
. 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.