Actively Recruiting
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke
Led by Beijing Anzhen Hospital · Updated on 2025-09-22
716
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- 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 or higher
- Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) 6 or higher; Posterior circulation: pc-ASPECTS 6 or higher
- 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% or less without planned angioplasty or stenting
You will not qualify if you...
- Intracranial hemorrhage confirmed by imaging prior to randomization or major intracranial hemorrhage on intraprocedural flat-panel CT
- Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset or major surgery within 14 days
- Bleeding diathesis including coagulopathy (platelets <100×10⁹/L, aPTT >50s, or INR >2.0), direct oral anticoagulant use within 48 hours, or history of heparin-induced thrombocytopenia
- Pregnancy or lactation at admission
- Contraindications to radiographic contrast agents, nickel, titanium, or their alloys
- Life expectancy less than 6 months
- Pre-existing neurological or psychiatric conditions that may interfere with assessment
- Severe renal insufficiency (glomerular filtration rate <30 mL/min or serum creatinine >220 μmol/L [2.5 mg/dL])
- Arterial tortuosity or anomalies preventing device delivery
- Unlikely to complete 90-day follow-up
- Any confirmed cardioembolic source including atrial fibrillation, valvular disease, intracardiac thrombus, recent myocardial infarction, cardiomyopathy with ejection fraction less than 30%, etc.
- Use of tirofiban or other GP IIb/IIIa inhibitors before randomization or after treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 101118
Actively Recruiting
Research Team
X
Xiaochuan Huo, Doctor
CONTACT
X
Xin Tong, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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