Actively Recruiting
Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke
Led by Beijing Anzhen Hospital · Updated on 2025-12-23
976
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, prospective, double-blind, placebo-controlled, randomized trial (ANGEL-DRUG2) aims to evaluate the efficacy and safety of intravenous tirofiban following intravenous thrombolysis in patients with acute ischemic stroke who show insufficient neurological improvement after initial treatment. Eligible patients (≥18 years, baseline NIHSS ≥4, within 4.5 hours from last known well) will be randomized 1:1 to receive either tirofiban or placebo infusion for 24 hours, followed by standard oral antiplatelet therapy. The primary endpoint is the proportion of patients achieving functional independence (mRS 0-2) at 90 days. Secondary outcomes include changes in NIHSS score, vessel recanalization, infarct volume, distribution of mRS scores, recurrent stroke, and health-related quality of life. Safety outcomes focus on symptomatic intracranial hemorrhage and all-cause mortality. Approximately 976 patients will be enrolled across 30 sites in China.
CONDITIONS
Official Title
Intravenous Thrombolysis Combined With Tirofiban in 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
- Symptoms of acute ischemic stroke within 4.5 hours of last known well time
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4 or greater
- Poor neurological improvement 1 hour after intravenous thrombolysis, defined as NIHSS decrease less than 2 points, or neurological worsening within 1 hour defined as NIHSS increase of 1 point or more
- Not planned for or not eligible for endovascular treatment
- Subject or legally authorized representative can provide written informed consent
You will not qualify if you...
- Evidence of intracranial hemorrhage on imaging before randomization
- Non-ischemic intracranial pathologies such as vascular malformation, aneurysm, tumor, abscess, or demyelinating disease
- Large or medium vessel stenosis requiring thrombectomy or intra-arterial thrombolysis
- Contraindications to tirofiban including known hypersensitivity, severe hepatic dysfunction (ALT >2x ULN or AST >2x ULN), severe renal dysfunction (serum creatinine >1.5x ULN), advanced heart failure (NYHA class III-IV), coagulation disorders or history of systemic bleeding, history of thrombocytopenia or neutropenia, prior drug-induced hematologic disease or liver dysfunction, leukopenia (<2x10^9/L) or platelet count <100x10^9/L
- Use of tirofiban or other GP IIb/IIIa inhibitors before randomization or planned use after randomization
- Definite cardioembolic source including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical prosthetic heart valves, infective endocarditis, history of intracardiac thrombus, recent myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous left atrial echo contrast, or left ventricular ejection fraction <30%
- Pregnancy or lactation
- Expected survival less than 6 months
- Pre-existing neurological or psychiatric disorders that may interfere with outcome assessment
- Unlikely to complete 90-day follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 101118
Actively Recruiting
Research Team
X
Xiaochuan Huo
CONTACT
X
Xin Tong
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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