NCT07379190 HR-MRI-Directed Tirofiban Therapy for Late-Window Acute Ischemic Stroke (TIAN)
| NCT ID | NCT07379190 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Weifang Medical University |
| Condition | Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 458 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 458 participants in total. It began in 2026-06-22 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to address the existing clinical challenges by introducing high-resolution magnetic resonance vessel wall imaging (HR-MRI), an advanced imaging technology, to achieve precise etiological classification in patients with acute ischemic stroke (AIS) beyond the time window. HR-MRI allows clear visualization of intracranial arterial wall structures and direct identification of key pathological features of the culprit vessel, including atherosclerotic plaques, vascular wall remodeling, and intracranial hemorrhage, thereby enabling reliable differentiation between intracranial atherosclerotic large artery atherosclerosis (ICAS-LAA) stroke and other etiological subtypes such as cardiogenic embolism. Based on the latest clinical demands and advances in imaging technology, this study intends to evaluate the efficacy and safety of tirofiban in patients with ICAS-LAA stroke beyond the time window under the precise guidance of HR-MRI. It is expected to provide high-level evidence-based medical evidence for this specific patient population and further optimize clinical diagnosis and treatment strategies.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old; 2. Acute ischemic stroke (AIS) in the anterior intracranial circulation (internal carotid artery system) confirmed by clinical symptoms and imaging examinations; 3. Time from symptom onset or last known normal state to randomization: \> 24 hours and ≤ 7 days; 4. Stroke subtype confirmed as intracranial large artery atherosclerosis (ICAS) by high-resolution vessel wall imaging (HR-VWI) according to the TOAST classification, with cardiogenic embolism and other etiologies excluded; 5. Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-20 at the time of randomization; 6. Signed informed consent form obtained from the patient or their legal representative. Exclusion Criteria: 1. Planned to receive reperfusion therapy (endovascular therapy or intravenous thrombolysis)； 2. Intracranial hemorrhage confirmed by computed tomography (CT)； 3. Definite or suspected cardiogenic embolism； 4. History of atrial fibrillation or current electrocardiogram indicating atrial fibrillation； 5. Acute ischemic stroke caused by other etiologies, such as Moyamoya disease, arterial dissection, arteritis, etc； 6. Imaging examinations indicating that the area of the current cerebral infarction exceeds 1/2 of the area of a single cerebral lobe; 7. Known contraindications to antiplatelet therapy, including hematochezia, gastrointestinal bleeding, or any other hemorrhagic disorders; 8. History of hypersensitivity to aspirin; 9. Definite indication for anticoagulant therapy expected during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state, etc.); 10. Complicated with malignant tumors, chronic hemodialysis, severe renal insufficiency (glomerular filtration rate \[GFR\] \< 30 ml/min or serum creatinine \[Cr\] \> 220 μmol/L (2.5 mg/dl)), or severe hepatic insufficiency (serum alanine aminotransferase \[ALT\] \> 2 times the upper limit of normal \[ULN\], or serum aspartate aminotransferase \[AST\] \> 2 times the ULN); 11. Severe heart failure (New York Heart Association \[NYHA\] Functional Classification Class III or IV); 12. Complicated with severe non-cardiovascular comorbidities, with an estimated survival time \< 6 months; 13. Concurrent new cerebral infarction in both anterior and posterior circulations; 14. Inability to complete the follow-up procedures; 15. Presence of other known neurological disorders that may complicate the follow-up; 16. Concurrent participation in other therapeutic clinical trials with incomplete treatment and follow-up; 17. Other conditions that the investigators consider inappropriate for enrollment in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07379190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07379190 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 458 participants.
Is NCT07379190 currently recruiting?
Yes, NCT07379190 is actively recruiting participants. Contact the research team at wfsrmyy_ky@163.com for enrollment information.
Where is the NCT07379190 trial being conducted?
This trial is being conducted at Weifang, China.
Who is sponsoring the NCT07379190 clinical trial?
NCT07379190 is sponsored by Weifang Medical University. The trial plans to enroll 458 participants.
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