Intracranial artery stenosis induced- ischemic stroke/transient ischemic attack
Conditions
Interventions
placebo control group:Normal saline at a dose of 0.4µg/kg/min was continuously infused for 30 minutes, followed by a maintenance dose of 0.1µg/kg/min for 23.5 hours
Tirofiban group:Tirofiban was continuously infused at a dose of 0.4µg/kg/min for 30 minutes, followed by a maintenance dose of 0.1µg/kg/min for 23.5 hours
Sponsors
Wuxi people’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.A stroke event has occurred within the past 14 days to 6 months (mRS score <= 4), and this stroke event was caused by stenosis due to atherosclerosis in the intracranial large arteries (internal carotid artery at C5-C7, middle cerebral artery at M1 segment, vertebral artery at V4 segment, or basilar artery); 3.The degree of stenosis in the affected blood vessel is 70–99% (according to the WASID criteria), and this has been confirmed by DSA; 4.The patient or their legal representative understands the purpose and requirements of the study and has signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Those who are known to be allergic to the trial medication during the screening period; 2.Those for whom it is known at the time of screening that the intracranial stenosis is caused by non-atherosclerotic factors, including but not limited to: dissecting aneurysm, Moyamoya disease, vasculitis, viral vasculopathy, neurosyphilis, intracranial infection, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, reversible vasospastic syndrome, postpartum vasculopathy, vasospasm, or suspected recanalization after vascular embolism; 3.In cases where the responsible blood vessel cannot be clearly identified, such as bilateral vertebral artery stenosis in the intracranial segment exceeding 70%, or a series of lesions in the same-side extracranial segment with stenosis exceeding 50%; 4.Those who are allergic to contrast agents; 5.Those for whom it is known during the screening period that the responsible lesion has severe calcification; 6.Those with excessively tortuous blood vessels, where it is anticipated that the device will not be able to pass smoothly; 7.Those who have undergone endovascular treatment on the same side within the past 30 days; 8.Those with stents implanted in the responsible lesion, or who have undergone other endovascular treatments within the past 6 months, such as balloon dilation; 9.Those with an infarction area exceeding half of the MCA (middle cerebral artery) supply area; 10.Those with severe impairment of consciousness at the time of screening: NIHSS cognitive score of 1a or higher (>=2 points); 11.Those with a NIHSS score of =25 points; 12.Presence of severe swallowing dysfunction, and the inability or refusal to receive oral medications through a nasogastric tube; 13.Recent bleeding confirmed by CT/MRI, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or epidural hemorrhage, excluding microhemorrhages in the brain detected by SWI; 14.Clinical suspicion of subarachnoid hemorrhage despite negative results on CT or MRI; 15.Patients with a known history of bleeding disorders, including hereditary or acquired bleeding disorders, coagulation factor deficiencies, or other conditions identified by the researchers as high-risk for intracranial hemorrhage; 16.Active gastrointestinal ulcers with current bleeding tendencies: International Normalized Ratio (INR) > 1.5 after correction, bleeding duration exceeding the upper limit of 1 minute, or an increased risk of bleeding due to heparin-induced thrombocytopenia; severe systemic bleeding within 30 days before enrollment; 17.Patients with established severe cardiac, hepatic, or renal insufficiency at the time of screening: New York Heart Association (NYHA) Class III or IV heart function; glomerular filtration rate (GFR) three times the upper limit of normal; creatinine clearance rate 265 µmol/L (3.0 mg/dL); creatine kinase > five times the upper limit of normal; 18.Those who have experienced significant head injuries within 30 days prior to enrollment; 19.Those who have large intracranial tumors, giant cerebral aneurysms, or arteriovenous malformations prior to enrollment; 20.Those with a history of neurological or mental illnesses that could affect neurological function scores or prognostic assessments; those with severe neurological deficits that prevent them from living in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stroke occurring within 24 hours after angioplasty;Symptomatic intracranial hemorrhage occurring within 72 hours after angioplasty; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stroke-related deaths within 90 days;Vascular death within 90 days;All deaths within 90 days;Incidence of adverse events within 90 days;Any form of intracranial hemorrhage within 90 days;Acute thrombosis at the lesion site within 30 minutes after angioplasty;Composite vascular endpoint events within 90 days; | — |
Countries
China
Contacts
Public ContactJiang Yongjun
Wuxi people’s Hospital
Outcome results
None listed