RecruitingNot ApplicableNCT06045156

Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Sponsor

The First Hospital of Jilin University

Enrollment

1,084 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke

Summary

The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Age≥18 years old;
Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;
Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT;
Tirofiban or placebo treatment can be initiated within 6h after IVT;
mRS score before onset≤ 1;
Intracranial hemorrhage is ruled out by CT head after IVT;

Exclusion Criteria14

Received or plan to undergo bridge therapy;
Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);
Atrial fibrillation or suspected cardiac embolism;
Accompanied by epileptic seizures;
Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;
Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;
Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;
Severe renal or liver insufficiency; ALT or AST>3 times of the upper limit of normal value or above; creatinine clearance rate<30 mL/min, creatinine>200μmol/L；
Life expectancy less than 3 months;
Pregnant or lactating women;
Known allergy to tirofiban;
Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;
Patients who are unwilling to be followed up or likely to have poor treatment compliance;
Other situations that the researcher deems unsuitable for inclusion in the study.