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RECRUITING

NCT07290751

PHASE4

Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

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.

Official title: Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke: A Multicenter, Prospective, Double-Blind, Placebo-Controlled, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

976

Start Date

2025-11-11

Completion Date

2026-12-31

Last Updated

2025-12-23

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

DRUG

Tirofiban

After intravenous thrombolysis, if neurological improvement is insufficient (NIHSS score decrease \<2 within 1 hour or NIHSS increase ≥1), tirofiban infusion is initiated within 1 hour. The regimen consists of 0.4 μg/kg/min for 30 minutes, followed by 0.1 μg/kg/min for 23.5 hours (total 24 hours). At the 20th hour of infusion, oral antiplatelet therapy (aspirin 100 mg once daily and/or clopidogrel 75 mg once daily) is initiated, overlapping with tirofiban for 4 hours (bridge therapy). At 24 hours, tirofiban infusion is completed, and patients continue oral antiplatelet therapy per protocol.

OTHER

Placebo (0.9% normal saline)

Matched normal saline infusion using the same dosing schedule and pump rates as the tirofiban arm (0.4 μg/kg/min for 30 minutes, then 0.1 μg/kg/min for 23.5 hours; total 24 hours). At the 20th hour of infusion, oral antiplatelet therapy (aspirin 100 mg once daily and/or clopidogrel 75 mg once daily) is initiated, overlapping with placebo infusion for 4 hours (bridge therapy). At 24 hours, placebo infusion is completed, and patients continue oral antiplatelet therapy per protocol.

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.

Locations (1)

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing Municipality, China