Acute ischemic stroke is a leading cause of disability and mortality among dults in China. Although intravenous thrombolysis serves as first-line reperfusion therapy, nearly half of patients fail to achieve vascular recanalization. The reocclusion rate ranges from 14% to 34%, and many patients are left with residual neurological deficits. Early antiplatelet therapy initiated after thrombolysis may sustain persistent reperfusion and improve prognosis. However, current guidelines generally recommend delaying antiplatelet treatment until 24 hours post-thrombolysis due to bleeding risks, and direct evidence for the optimal initiation timing remains lacking. Tirofiban is a rapidly acting, short-half-life, reversible glycoprotein IIb/IIIa receptor antagonist. Previous studies indicate its potential benefits and acceptable safety when administered after intravenous thrombolysis.
This is a multicenter, three-arm, open-label, endpoint-blinded randomized controlled trial. A total of 1482 non-cardioembolic patients without large or medium vessel occlusion and with residual neurological deficits (NIHSS ≥4) after thrombolysis will be enrolled. Participants will be randomly allocated to the tirofiban 24-hour group, tirofiban 48-hour group, or blank control group. The primary outcome is the proportion of patients with excellent functional outcome defined as modified Rankin Scale (mRS) score 0-1 at 90 days. Symptomatic intracranial hemorrhage and neurological outcomes will also be evaluated. The study aims to determine the optimal duration of tirofiban treatment after thrombolysis and provide high-level evidence for precise interventions in the acute phase of stroke.
Age ≥ 18 years.
Diagnosis of acute ischemic stroke meeting the diagnostic criteria from Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023, and the patient has received intravenous thrombolysis with tenecteplase, alteplase or reteplase.
Disabling stroke remains at 2-24 hours after completion of intravenous thrombolysis. Disabling stroke is defined as NIHSS score ≥ 4, or single limb motor subscore ≥ 2.
Written informed consent is obtained from the patient or legal representative.
Intracranial hemorrhage confirmed by CT or MRI after intravenous thrombolysis and prior to randomization.
CTA/MRA/DSA demonstrates occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, anterior cerebral artery, or vertebrobasilar artery.
History of atrial fibrillation or suspected cardioembolic stroke. Platelet count <100×10⁹/L on routine blood test.
Renal insufficiency with estimated glomerular filtration rate (eGFR) <30 mL/min.
Parallel
Tirofiban Injection
DrugIntravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 24 hours. The dosage regimen follows the trial protocol.
Tirofiban Injection
DrugIntravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 48 hours. The dosage regimen follows the trial protocol.
No Interventions
Other interventionNo tirofiban will be administered after intravenous thrombolysis. Patients receive routine standard clinical management according to hospital guidelines.
Proportion of patients with mRS 0-1 at 90 days
Percentage of participants achieving modified Rankin Scale (mRS) score 0 or 1 at 90 days after randomization.
mRS score at 90 days
Modified Rankin Scale (mRS) score assessed at 90 days after randomization.
EQ-5D-5L score at 90 days
EQ-5D-5L questionnaire score assessed at 90 days after randomization.
Proportion of patients with mRS 0-2 at 90 days
Percentage of participants achieving modified Rankin Scale (mRS) score 0 to 2 at 90 days after randomization.
Proportion of patients with mRS 0-3 at 90 days
Percentage of participants achieving modified Rankin Scale (mRS) score 0 to 3 at 90 days after randomization.
Incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours
Proportion of participants with symptomatic intracranial hemorrhage (sICH) within 48 hours after randomization, defined by the Heidelberg criteria.
Incidence of any intracranial hemorrhage (any ICH) within 48 hours
Proportion of participants with any intracranial hemorrhage (any ICH) within 48 hours after randomization.
90-day mortality
Proportion of participants who die within 90 days after randomization.
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Xinqiao Hospital of Chongqing
Lead sponsor
The Affiliated Ganzhou Hospital of Nanchang University
Collaborator
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