A prospective, multicenter, randomized, controlled, open-label, blinded endpoint trial to evaluate the safety and efficacy of intravenous administration of tirofiban for preventing early neurological deterioration after intravenous thrombolysis in patients with acute ischemic stroke.
Age ≥18 years old;
Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.
Residual NIHSS score ≥ 5 points at randomization (at least 1 hour after intravenous thrombolytic therapy).
Post-thrombolysis imaging shows that the offending artery is consistent with moderate or severe intracranial atherosclerotic stenosis (within 50%~99%)
Intracranial hemorrhage confirmed by imaging post-thrombolysis.
Stroke caused by other determined causes, including moyamoya disease, artery dissection, arteritis, etc.
Scheduled for or received endovascular treatment after onset.
Definite or suspected cardioembolic stroke.
Parallel
Tirofiban Hydrochloride
DrugTirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion until 24 hours after Intravenous thrombolytic therapy, or use a loading dose, 25 μg/kg, administrated within 3 minutes, then 0.15μg/kg/min infusion until 24 hours after Intravenous thrombolytic therapy.
Standard medical treatment (SMT)
DrugPatients will receive standard antiplatelet therapy.
Proportion of patients experiencing neurological deterioration within 24 hours after intravenous thrombolysis.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale ranging from 0-42. A higher score means more severe stroke symptoms. Neurological deterioration is defined as an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS.
Change of the NIHSS
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 30-day follow up.
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up.
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 30-day follow up.
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
Biomarkers levels of groups
The biomarkers include CLEC2, CD62P, TXB2, 6-k-PGFla, EETs, 20-HETE, BCAA, ALDH2
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Capital Medical University
Lead sponsor
Xuanwu Hospital, Beijing
Sponsor institution
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