Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke

Launched by BEIJING ANZHEN HOSPITAL · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people who have had a type of stroke called an acute ischemic stroke caused by a blockage in a large blood vessel in the brain. Researchers want to see if adding a medicine called tirofiban, given after a procedure to remove the blockage (called endovascular therapy), can improve recovery and help patients regain their independence three months later. They will compare patients who receive tirofiban with those who get a placebo (a treatment without the active medicine) to find out if tirofiban is both safe and effective.

Adults who have had a recent stroke (within 24 hours), with moderate to severe symptoms, and who are planned to have the clot removed through endovascular therapy may be eligible to participate. To join, patients should not have had serious bleeding recently or certain medical conditions that increase bleeding risk. If accepted, participants will receive the usual clot-removal procedure and then be randomly given either tirofiban or a placebo. Doctors will closely watch for any bleeding in the brain and track how well patients recover over the next three months. This study hopes to find better treatments to help stroke patients recover more fully and safely.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years
• • 2. Pre-stroke modified Rankin Scale (mRS) score of 0-1
• • 3. Acute ischemic stroke symptoms present within 24 hours of last known well time
• • 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6
• • 5. Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6
• • 6. Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery
• • 7. Clinical care team plans to perform endovascular thrombectomy (EVT)
• • 8. Subject or legally authorized representative can provide informed consent
• • 9. Residual stenosis ≥50% without planned angioplasty/stenting
• Exclusion Criteria:
• • 1. Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT
• • 2. Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days
• • 3. Bleeding diathesis including coagulopathy (platelets \<100×10⁹/L, aPTT \>50s, or INR \>2.0), DOAC use within 48 hours, or history of HIT
• • 4. Pregnancy or lactation at admission
• • 5. Contraindications to radiographic contrast agents, nickel, titanium or their alloys
• • 6. Life expectancy \<6 months
• • 7. Pre-existing neurological/psychiatric conditions that may confound assessment
• • 8. Severe renal insufficiency (GFR \<30mL/min or Scr \>220μmol/L \[2.5mg/dL\])
• • 9. Arterial tortuosity or anomalies preventing device delivery
• • 10. Unlikely to complete 90-day follow-up
• • 11. Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF \<30%, etc.)
• • 12. Tirofiban or other GP IIb/IIIa inhibitor use before randomization or other GP IIb/IIIa inhibitor used post treatment