NCT07290751RecruitingPhase 4
Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke
Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke: A Multicenter, Prospective, Double-Blind, Placebo-Controlled, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 976 (estimated)
- First submitted
- 29 Aug 2025
- Start date
- 11 Nov 2025
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Stroke
- NCT number
- NCT07290751
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 976
- From 11 Nov 2025 to the primary completion date, 30 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of tirofiban or other GP IIb/IIIa inhibitors before randomization, or planned use of such agents after randomization.
Other illness
- 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.
Lab values
- 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%.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.