Adding intravenous tirofiban after clot-busting treatment for patients who don't improve quickly from acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ANGEL-DRUG2 is a multicenter, double-blind, placebo-controlled randomized trial enrolling about 976 patients who received intravenous thrombolysis within 4.5 hours but showed insufficient neurological improvement at 1 hour. Participants are randomized 1:1 to a 24-hour tirofiban infusion (loading then maintenance dose) or matching placebo, with transition to standard oral antiplatelet therapy during the infusion. The primary outcome is functional independence (mRS 0-2) at 90 days, and secondary outcomes include NIHSS change, vessel recanalization, infarct volume, recurrent stroke, and quality of life. Safety monitoring focuses on symptomatic intracranial hemorrhage and all-cause mortality.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anzhen Hospital,Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaochuan Huo
• Email: huoxiaochuan@126.com
• Phone: +8613716292262

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.