HR-MRI-Directed Tirofiban Therapy for Late-Window Acute Ischemic Stroke (TIAN)

ConditionsStroke, Acute Stroke, Ischemic Cerebral Infarction

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorWeifang Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Planned to receive reperfusion therapy (endovascular therapy or intravenous thrombolysis)；

Intracranial hemorrhage confirmed by computed tomography (CT)；

Definite or suspected cardiogenic embolism；

History of atrial fibrillation or current electrocardiogram indicating atrial fibrillation；

Trial design

Design model

Parallel

Treatments tested in this trial

Tirofiban
Drug
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.
dual antiplatelet therapy
Drug
Initiate dual antiplatelet therapy as early as possible (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. For patients at high risk of stroke, such as those with severe stenosis of major blood vessels, dual antiplatelet therapy should be administered for 90 days.

Treatment groups

458 Participants

are divided into 2 treatment groups

Group A: Tirofiban Combined with Standard Medication Therapy GroupExperimental treatment 2 interventions

Group B: Standard Medication Therapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of participants with functional independence outcome [modified Rankin Scale(mRS) score 0-1]

the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death); a lower score indicates a better prognosis.

Time frame