Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT07290751
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07290751
Study Brief:
Protocol Section:
NCT07290751