Cerebral Infarction, Stroke, Acute, Stroke, Ischemic
Conditions
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.
Interventions
DRUGTirofiban
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.
DRUGdual antiplatelet therapy
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.
Sponsors
Weifang Medical University
Linyi People's Hospital
Qianfoshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with functional independence outcome [modified Rankin Scale(mRS) score 0-1] | 90 ± 7 days after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with good prognosis (mRS score 0-2) | 90 ± 7 days after randomization | 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. |
| Proportion of participants with mRS score 0-3 | 90 ± 7 days after randomization | 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. |
| Distribution of mRS scores | 90 ± 7 days after randomization | 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. |
| EuroQol Five-Dimension Questionnaire (EQ-5D) score | 90 ± 7 days after randomization | 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. |
| Barthel Index (BI) score | 90 ± 7 days after randomization | the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis); |
| 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] | 24 ± 6 hours | the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits); |
| National Institutes of Health Stroke Scale (NIHSS) scores | Time Frame: 24h; before discharge; day7 | 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) |
| Proportion of participants with symptomatic intracranial hemorrhage (sICH) within 24 hours of randomization | 24 ± 6 hours | clinical safety endpoint |
| Early neurological deterioration(END) | 24 ± 6 hours | defined as NIHSS score increased by #4 points within 24 hours |
| Incidence of serious adverse events (SAEs) | 24 ± 6 hours; | clinical safety endpoint |
| Incidence of any adverse events | 24 ± 6 hours; | clinical safety endpoint |
| Recurrent stroke | 90 ± 7 days after randomization | 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. |
| all-cause mortality; | 90 ± 7 days after randomization | clinical safety endpoint; to observe the proportion of all patients who died in each group |
| stroke-related mortality | 90 ± 7 days after randomization | clinical safety endpoint;The proportion of stroke related deaths in each group |
| Proportion of participants with any intracranial hemorrhage | 24 ± 6 hours | imaging safety endpoints; to observe the proportion of intracranial hemorrhage patients in each group |
Countries
China
Contacts
CONTACTWeili Li, MD
Outcome results
None listed