Endovascular treatment plus tirofiban for strokes from intracranial atherosclerosis

Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial

This trial will see if giving tirofiban after endovascular clot removal helps people with acute large-vessel ischemic stroke caused by intracranial atherosclerosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 716 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07026318 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with acute anterior or posterior large-vessel occlusion from intracranial atherosclerosis who are planned for endovascular thrombectomy within 24 hours, have pre-stroke mRS 0–1 and NIHSS ≥6, and show residual stenosis ≥50% without planned angioplasty/stenting are ideal candidates.

Not a fit: Patients with intracranial hemorrhage, recent major bleeding or surgery, planned angioplasty/stenting, severe pre-stroke disability, or strokes not due to intracranial atherosclerotic large-vessel occlusion are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding tirofiban could increase the proportion of patients who regain functional independence at 90 days after stroke.

How similar studies have performed: Prior observational studies and small randomized trials of glycoprotein IIb/IIIa inhibitors like tirofiban during EVT have suggested potential benefit for atherosclerotic occlusions, but robust randomized evidence is still limited.

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

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Xiaochuan Huo, Doctor

Conditions Acute Ischemic Stroke; Tirofiban; placebo; Randomized Controlled Trial; Intracranial Atherosclerotic