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Efficacy and Safety of Tirofiban Therapy in Acute Ischemic Stroke Patients Beyond the Time Window Guided by High-Resolution Magnetic Resonance Imaging

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old;

• Acute ischemic stroke (AIS) in the anterior intracranial circulation (internal carotid artery system) confirmed by clinical symptoms and imaging examinations;

• Time from symptom onset or last known normal state to randomization: \> 24 hours and ≤ 7 days;

• 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;

• Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-20 at the time of randomization;

• Signed informed consent form obtained from the patient or their legal representative.

Locations
Other Locations
China
Weifang People's Hospital
RECRUITING
Weifang
Contact Information
Primary
Weili Li, MD
wfsrmyy_ky@163.com
86-0536-8192680
Time Frame
Start Date: 2026-06-22
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 458
Treatments
Experimental: Tirofiban Combined with Standard Medication Therapy Group
Patients were randomized to the Tirofiban Combined with Dual Antiplatelet Therapy Group. Intravenous tirofiban was administered within 30 minutes of randomization, with an initial bolus infusion at a rate of 0.4 μg/(kg·min) for 30 minutes, followed by a continuous infusion at 0.1 μg/(kg·min) for 47.5 hours. During this period, dual antiplatelet therapy (DAPT) was initiated at a dose of aspirin 100 mg/day plus clopidogrel 75 mg/day, with an overlapping duration of 4-6 hours. After the completion of tirofiban infusion, dual antiplatelet therapy (aspirin 100 mg/day plus clopidogrel 75 mg/day) was continued for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone.
Active_comparator: Standard Medication Therapy Group
Patients were randomized to the control group, with dual antiplatelet therapy (DAPT) initiated as early as possible at a dose of aspirin 100 mg/day plus clopidogrel 75 mg/day for a total of 21 days, followed by long-term maintenance with aspirin 100 mg/day alone.
Related Therapeutic Areas
Sponsors
Leads: Weifang Medical University
Collaborators: Linyi People's Hospital, Qianfoshan Hospital

This content was sourced from clinicaltrials.gov