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

Last updated: May 1, 2025
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Overall Status: Completed

Phase

3

Condition

Stroke

Thrombosis

Blood Clots

Treatment

Intravenous thrombolysis plus tirofiban

Intravenous thrombolysis plus placebo

Clinical Study ID

NCT06134622
ASSET-IT
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Onset of ischemic stroke symptoms within ≤ 4.5 hours*, treated with intravenousrt-PA or TNK according to guidelines;

  2. NIHSS score of 4-25 before intravenous thrombolysis;

  3. Age ≥ 18 years;

  4. Able to receive the designated study drug within 60 minutes after intravenousthrombolysis;

  5. Informed consent signed by the patient or their legal representative. *Symptom onsetis defined as the last known well time.

Exclusion

Exclusion Criteria:

  1. Presence of contraindications to intravenous thrombolysis;

  2. Pre-stroke mRS score > 1;

  3. Patients planned to undergo mechanical thrombectomy or other endovascular treatments (e.g., intra-arterial thrombolysis);

  4. Patients with a history of atrial fibrillation or emergency ECG indicating atrialfibrillation;

  5. Pregnant or lactating women;

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

  7. If NIHSS worsens by 2 or more points between start of thrombolysis and start ofstudy drug, repeat brain imaging rules out new intracranial hemorrhage;

  8. Severe leukoaraiosis;

  9. Currently participating in other clinical trials;

  10. Known genetic or acquired bleeding diathesis, or received warfarin and INR > 1.7; ortreated with direct oral anticoagulant agents in the prior 48 hours;

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

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

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

  14. Life expectancy < 1 year;

  15. Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patients,etc.).

Study Design

Total Participants: 832
Treatment Group(s): 2
Primary Treatment: Intravenous thrombolysis plus tirofiban
Phase: 3
Study Start date:
March 14, 2024
Estimated Completion Date:
December 30, 2024

Study Description

The standard treatment for acute ischemic stroke is intravenous thrombolysis to dissolve fibrin and restore blood flow. However, reocclusion of blood vessels and stroke progression remain challenges after this treatment.

Connect with a study center

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui 230001
    China

    Site Not Available

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