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| Name | Class |
|---|---|
| Linyi People's Hospital | OTHER |
| Qianfoshan Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirofiban Combined with Standard Medication Therapy Group | Experimental | 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. |
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| Standard Medication Therapy Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 ± 7 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 ± 7 days after randomization |
| Proportion of participants with mRS score 0-3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Li, MD | Contact | 86-0536-8192680 | wfsrmyy_ky@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weifang People's Hospital | Recruiting | Weifang | China/Shandong Province | 261000 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| 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. |
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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. |
| 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. | 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. | 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); | 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); | 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: 24h; before discharge; day7 |
| Proportion of participants with symptomatic intracranial hemorrhage (sICH) within 24 hours of randomization | clinical safety endpoint | 24 ± 6 hours |
| Early neurological deterioration(END) | defined as NIHSS score increased by #4 points within 24 hours | 24 ± 6 hours |
| Incidence of serious adverse events (SAEs) | clinical safety endpoint | 24 ± 6 hours; |
| Incidence of any adverse events | clinical safety endpoint | 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. | 90 ± 7 days after randomization |
| all-cause mortality; | clinical safety endpoint; to observe the proportion of all patients who died in each group | 90 ± 7 days after randomization |
| stroke-related mortality | clinical safety endpoint;The proportion of stroke related deaths in each group | 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 | 24 ± 6 hours |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |