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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
458
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.
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.
Weifang People's Hospital
Weifang, China/Shandong Province, China
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: 90 ± 7 days after randomization
Proportion of participants with good prognosis (mRS score 0-2)
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: 90 ± 7 days after randomization
Proportion of participants with mRS score 0-3
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: 90 ± 7 days after randomization
Distribution of mRS scores
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: 90 ± 7 days after randomization
EuroQol Five-Dimension Questionnaire (EQ-5D) score
The EQ-5D is a standardized patient-reported outcome measure for evaluating health-related quality of life (HRQoL), consisting of the EQ-5D descriptive system (assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the EQ visual analog scale (EQ-VAS). The utility score derived from the descriptive system will be adopted for statistical analysis, with a range of -0.594 to 1.0 based on the applicable value set. A higher score indicates better health-related quality of life: a score of 1.0 represents perfect health, 0 equates to a health state equivalent to death, and negative scores reflect health states worse than death. The EQ-VAS (0-100 scale, 0 = worst imaginable health state; 100 = best imaginable health state) will be analyzed as a supplementary index.
Time frame: 90 ± 7 days after randomization
Barthel Index (BI) score
the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);
Time frame: 90 ± 7 days after randomization
Proportion of participants with neurological improvement within 24 hours of randomization [≥2-point reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline]
the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);
Time frame: 24 ± 6 hours
National Institutes of Health Stroke Scale (NIHSS) scores
NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)
Time frame: Time Frame: 24h; before discharge; day7
Proportion of participants with symptomatic intracranial hemorrhage (sICH) within 24 hours of randomization
clinical safety endpoint
Time frame: 24 ± 6 hours
Early neurological deterioration(END)
defined as NIHSS score increased by #4 points within 24 hours
Time frame: 24 ± 6 hours
Incidence of serious adverse events (SAEs)
clinical safety endpoint
Time frame: 24 ± 6 hours;
Incidence of any adverse events
clinical safety endpoint
Time frame: 24 ± 6 hours;
Recurrent stroke
clinical safety endpoint;the new neurological deficit must be accompanied by corresponding new ischemic or hemorrhagic lesions on brain CT or MRI, which are not contiguous with the index stroke lesion and do not correspond to the vascular territory of the index stroke.
Time frame: 90 ± 7 days after randomization
all-cause mortality;
clinical safety endpoint; to observe the proportion of all patients who died in each group
Time frame: 90 ± 7 days after randomization
stroke-related mortality
clinical safety endpoint;The proportion of stroke related deaths in each group
Time frame: 90 ± 7 days after randomization
Proportion of participants with any intracranial hemorrhage
imaging safety endpoints; to observe the proportion of intracranial hemorrhage patients in each group
Time frame: 24 ± 6 hours
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