Tirofiban With Endovascular Therapy for Blocked Brain Arteries From Atherosclerosis
Tests tirofiban added to clot removal in adults with acute stroke from atherosclerosis.
Plain-language title generated from the registry record
Registry title: Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Beijing Anzhen Hospital Affiliated to Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Anzhen Hospital
- Trial code
- NCT07026318
- Record updated
- 22 September 2025
- Original description
This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.Read full original descriptionShow less
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial
This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.
Inclusion: Age ≥18 years; Pre-stroke modified Rankin Scale (mRS) score of 0-1; Acute ischemic stroke symptoms present within 24 hours of last known well time; Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6; Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6; Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery; Clinical care team plans to perform endovascular thrombectomy (EVT); Subject or legally authorized representative can provide informed consent; Residual stenosis ≥50% without planned angioplasty/stenting.
Exclusion: Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT; Tirofiban or other GP IIb/IIIa inhibitor use before randomization or other GP IIb/IIIa inhibitor used post treatment; Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days; Pre-existing neurological/psychiatric conditions that may confound assessment; Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF <30%, etc.); Bleeding diathesis including coagulopathy (platelets <100×10⁹/L, aPTT >50s, or INR >2.0), DOAC use within 48 hours, or history of HIT; Severe renal insufficiency (GFR <30mL/min or Scr >220μmol/L [2.5mg/dL]); Pregnancy or lactation at admission; Contraindications to radiographic contrast agents, nickel, titanium or their alloys; Life expectancy <6 months; Arterial tortuosity or anomalies preventing device delivery; Unlikely to complete 90-day follow-up.