This study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke.
This multicenter, prospective, randomized, controlled trial assesses the efficacy and safety of intravenous tenecteplase for acute posterior-circulation ischemic stroke treated 4.5-24 hours after onset. Participants with imaging-confirmed stroke will be randomly assigned 1:1 to receive either tenecteplase or standard medical therapy. Eligible patients must present within 4.5-24 hours from symptom onset, defined as the midpoint between last known normal and first observed neurological deficit. All participants will undergo telephone follow-up at 3 months and 1 year, with the modified Rankin Scale as the primary outcome measure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
406
Patients in the TNK treatment group will receive TNK intravenous thrombolysis and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg.
standard medical management
The First Affiliated Hospital of the University of Science and Technology of China
Hefei, China
RECRUITINGProportion of patients with modified Rankin Scale (mRS) score 0-1 at 90 ±14 days;
Time frame: 90 ±14 days
Proportion of patients with mRS score 0-2 at 90 ±14 days;
Time frame: 90 ±14 days
Proportion of patients with mRS score 0-3 at 90 ±14 days;
Time frame: 90 ±14 days
Ordinal distribution of mRS score at 90 ±14 days;
Time frame: 90 ±14 days
Change in NIHSS score at 24-36 hours post-treatment
Time frame: 24 hours post-treatment
5)Change in NIHSS score at 5-7 days post-treatment;
Time frame: 5-7 days post-treatment
EQ-5D-5L questionnaire score at 90 ±14 days;
Time frame: 90 ±14 days
Barthel Index score at 90 ±14 days;
Time frame: 90 ±14 days
1)Symptomatic intracranial hemorrhage within 36 hours (Heidelberg criteria)
Time frame: 24-36 hours after treatment
Any intracranial hemorrhage within 36 hours (Heidelberg criteria)
Time frame: 24-36 hours after treatment
Mortality rate at 90 ±14 days
Time frame: 90 ±14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall incidence of serious adverse events
Time frame: 90 ±14 days