Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Guangxi Medical University
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
- Standard medical treatment
Treatment groups
352 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov