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 range18 Years
SexALL
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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
✕. 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.
What they're measuring
1
Excellent outcome
Timeframe: 90 (±14) days
Trial details
NCT IDNCT07475949
SponsorFirst Affiliated Hospital of Guangxi Medical University