Endovascular treatment plus tirofiban for strokes from intracranial atherosclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled trial that gives patients tirofiban or matching placebo after endovascular thrombectomy for acute large-vessel occlusion due to intracranial atherosclerosis. Eligible adults present within 24 hours, have moderate-to-severe deficits (NIHSS ≥6) and adequate imaging scores (ASPECTS/pc-ASPECTS ≥6), and have residual intracranial stenosis ≥50% without planned angioplasty or stenting. The primary efficacy outcome is functional independence (mRS 0–2) at 90±7 days and the primary safety outcome is symptomatic intracranial hemorrhage within 48 hours. The trial is conducted at Beijing Anzhen Hospital and randomizes patients to adjunctive tirofiban versus placebo after EVT.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Anzhen Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaochuan Huo, Doctor
• Email: hxc810909@163.com
• Phone: +86 13716292262

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.