Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)

• Status: Not yet recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of University of Science and Technology of China
• Treatments: Tirofiban

Criteria

Inclusion Criteria:

1. Onset of ischemic stroke symptoms ≤4;5 hours, treated with intravenous alteplase or tenecteplase according to guidelines;

2. NIHSS score before intravenous thrombolysis ≤25;

3. Age ≥18 and ≤80 years;

4. Patient or legal representative signs an informed consent form.

Exclusion Criteria:

1. Presence of contraindications for intravenous thrombolysis;

2. Pre-stroke mRS score >1;

3. Patients undergoing mechanical thrombectomy or other intravascular treatments (e;g;, intra-arterial thrombolysis);

4. Known history of atrial fibrillation or emergency electrocardiogram indicating atrial fibrillation;

5. Pregnant or lactating women;

6. NCCT, CTA source images, or MRI-DWI showing ASPECTS or PC-ASPECTS <6;

7. Currently participating in other clinical trials;

8. Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours;

9. Severe renal failure, defined as serum creatinine >3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate [GFR] <30, or patients requiring hemodialysis or peritoneal dialysis;

10. Liver dysfunction (ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal);

11. Known allergy to tirofiban or other IIb/IIIa inhibitors;

12. Expected lifespan <1 year;

13. Patients unable to complete the 90-day follow-up (e.g., no fixed residence, overseas patients).