NCT07290751 Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 976 participants in total. It began in 2025-11-11 with a primary completion date of 2026-10-30.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years. 2. Pre-stroke modified Rankin Scale (mRS) score of 0-1. 3. Acute ischemic stroke symptoms within 4.5 hours of last known well time. 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4. 5. 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. 6. Not planned for or not eligible for endovascular treatment. 7. Subject or legally authorized representative can provide written informed consent. Exclusion Criteria: 1. Evidence of intracranial hemorrhage on imaging before randomization. 2. Non-ischemic intracranial pathologies, such as vascular malformation, aneurysm, tumor, abscess, or demyelinating disease. 3. Large or medium vessel stenosis requiring thrombectomy or intra-arterial thrombolysis. 4. 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. 5. Use of tirofiban or other GP IIb/IIIa inhibitors before randomization, or planned use of such agents after randomization. 6. 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%. 7. Pregnancy or lactation. 8. Expected survival \<6 months. 9. Pre-existing neurological or psychiatric disorders that may interfere with outcome assessment. 10. Unlikely to complete 90-day follow-up.

Contact & Investigator

Frequently Asked Questions

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.