Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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.
Planned endovascular treatment.
Rapid neurological improvement with NIHSS <6 at randomization.
Allergy to tenecteplase.
Trial design
Design model
Parallel
Treatments tested in this trial
Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
DrugTenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization.
Standard medical treatment
Other interventionStandard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.
Treatment groups
352 Participants
are divided into 2 treatment groupsGroup A: Control groupOther 1 intervention
Group B: Tenecteplase groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Excellent outcome
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
Time frame
90 (±14) daysSecondary outcomes
1
Level of disability
Ordinal shift analysis of the mRS with 5-6 merged at 90 days.
Time frame
90 (±14) days2
Functional independence
The proportion of mRS score of 0-2 at 90 days.
Time frame
90 (±14) days3
Early neurological improvement
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours.
Time frame
24 (±12) hours4
Change in stroke severity
The change of NIHSS score from baseline to 7 days or at discharge (whichever comes first)
Time frame
7 (±1) days or at dischargeOther outcomes
1
Symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage within 36 hours from randomization (Heidelberg criteria)
Time frame
24 (±12) hours2
Any intracranial hemorrhage
Incidence of any intracranial hemorrhage within 36 hours from randomization (Heidelberg classification)
Time frame
24 (±12) hours3
Extracranial bleeding
Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from randomization
Time frame
24 (±12) hours4
Mortality
All cause death within 90 days.
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov