Status:
RECRUITING
Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT
Detailed Description
Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
1084 Patients enrolled
Trial Details
Trial ID
NCT06045156
Start Date
April 29 2024
End Date
December 30 2026
Last Update
December 30 2025
Active Locations (1)
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1
The first hospital of Jilin University
Changchun, Jilin, China, 130000