Early use of tirofiban after thrombolysis for acute ischemic stroke

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

This study is testing if giving tirofiban right after a stroke treatment can help patients recover better and stay safe.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1084 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06045156 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of administering tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, shortly after intravenous thrombolysis (IVT) in patients with acute ischemic stroke. The trial aims to determine if early tirofiban treatment can improve functional outcomes for patients who have undergone IVT, as previous studies with smaller sample sizes suggested potential benefits. Participants will be monitored for both efficacy and safety following the administration of tirofiban or a placebo within six hours after IVT.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with acute ischemic stroke and received standard IVT treatment within 4.5 hours of symptom onset.

Not a fit: Patients with large infarcts, active bleeding, or those who have received certain anticoagulant therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: While some smaller studies have indicated potential benefits of early tirofiban administration, this trial represents a more comprehensive evaluation of its efficacy in a larger cohort.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Received or plan to undergo bridge therapy;
2. Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);
3. Atrial fibrillation or suspected cardiac embolism;
4. Accompanied by epileptic seizures;
5. Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;
6. Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;
7. Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;
8. 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；
9. Life expectancy less than 3 months;
10. Pregnant or lactating women;
11. Known allergy to tirofiban;
12. Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;
13. Patients who are unwilling to be followed up or likely to have poor treatment compliance;
14. Other situations that the researcher deems unsuitable for inclusion in the study.

Where this trial is running

Changchun, Jilin

• The first hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Conditions Acute Ischemic Stroke; acute ischemic stroke; intravenous thrombolysis; tirofiban