Tirofiban after clot-dissolving treatment in people with acute ischemic stroke
Tests tirofiban against placebo after clot-dissolving treatment in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a stroke caused by a blocked blood vessel and are not improving enough after clot-dissolving treatment. Half get tirofiban and half get a placebo.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke with symptoms starting within 4.5 hours of last known well. Baseline NIHSS score of 4 or more. Pre-stroke mRS score of 0-1.
- Earlier treatment
- Must have had intravenous thrombolysis, with poor improvement 1 hour later (NIHSS decrease <2 points) or worsening within 1 hour (NIHSS increase ≥1 point). Must not have used tirofiban or other GP IIb/IIIa inhibitors before joining.
Main reasons for not taking part
- Bleeding in the brain on imaging before randomization
- Planned for or needing thrombectomy or intra-arterial thrombolysis
- Definite heart source of clots, such as atrial fibrillation or mechanical heart valves
- Pregnancy or breastfeeding
- Expected survival under 6 months
Read by machine on 9 November 2026.
Where in China
- Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaContact: Xiaochuan HuoTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Anzhen Hospital
- Trial code
- NCT07290751
- Record updated
- 23 December 2025
- Original description
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.Read full original descriptionShow less
Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke: A Multicenter, Prospective, Double-Blind, Placebo-Controlled, Randomized Controlled Trial
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.
Inclusion: Age ≥18 years; Pre-stroke modified Rankin Scale (mRS) score of 0-1; Acute ischemic stroke symptoms within 4.5 hours of last known well time; Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4; Poor neurological improvement 1 hour after intravenous thrombolysis, defined as NIHSS decrease <2 points, or neurological worsening within 1 hour, defined as NIHSS increase ≥1 point; Not planned for or not eligible for endovascular treatment; Subject or legally authorized representative can provide written informed consent.
Exclusion: Use of tirofiban or other GP IIb/IIIa inhibitors before randomization, or planned use of such agents after randomization; Evidence of intracranial hemorrhage on imaging before randomization; Non-ischemic intracranial pathologies, such as vascular malformation, aneurysm, tumor, abscess, or demyelinating disease; Pre-existing neurological or psychiatric disorders that may interfere with outcome assessment; Contraindications to tirofiban, including but not limited to:Known hypersensitivity to tirofiban; Severe hepatic dysfunction (ALT >2× ULN or AST >2× ULN); Severe renal dysfunction (serum creatinine >1.5× 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 (<2×10\^9/L) or platelet count <100×10\^9/L; Definite cardioembolic source, including but not limited to: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical prosthetic heart valves, infective endocarditis, history of intracardiac thrombus, myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous left atrial echo contrast, or left ventricular ejection fraction <30%; Large or medium vessel stenosis requiring thrombectomy or intra-arterial thrombolysis; Pregnancy or lactation; Expected survival <6 months; Unlikely to complete 90-day follow-up.