acute ischemic stroke
Conditions
Interventions
tirofiban group:IV tirofiban and endovascular treatment
placebo control group:IV placebo and endovascular treatment
Sponsors
Xinqiao Hospital, the Third Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Aged 18 years or older; (2) Presenting with acute ischemic stroke with symptoms within 24 hours of time last known well; (3) Baseline National Institutes of Health Stroke Scale (NIHSS) score = 6; (5) Occlusion of the intracranial internal carotid artery, the first or second segment of the middle cerebral artery (MCA-M1 or -M2) confirmed by CT, MR angiography, or digital subtraction angiography; (6) Planned treatment with endovascular treatment by clinical care team; (7) Informed consent obtained from patients or their legal representatives.
Exclusion criteria
Exclusion criteria: (1) CT or MR evidence of hemorrhage; (2) Dual antiplatelet therapy within 1 week of the index stroke; (3) Treated with intravenous thrombolysis after the index stroke; (4) Currently pregnant or lactating (women patients); (5) Allergy to tirofiban, radiographic contrast agents, or nitinol devices; (6) Gastrointestinal or urinary tract hemorrhage within 30 days of the index stroke; (7) Any major surgery within 14 days of the index stroke; (8) History of heparin-induced thrombocytopenia; (9) Any terminal illness with life expectancy less than 6 months; (10) Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; (11) Platelet count of routine blood test 220µmol/L (2.5mg/dl)); (13) Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; (14) Unlikely to be available for 90-day follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score at 90 days;Symptomatic intracerebral hemorrhage rate within 48 h;Mortality rate at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Proportion of patients non-disabled (mRS score 0 to 1) at 90 days or return to pre-morbid mRS score at 90 days (for patients with mRS > 1);(2) Proportion of patients functionally independent (mRS score 0 to 2) at 90 days;(3) Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3);Vessel recanalization rate immediately after endovascular treatment;Vessel recanalization rate evaluated by CTA or MRA within 48h;Vessel reocclusion rate immediately after endovascular treatment;Substantial reperfusion (eTICI 2b to 3) at final angiogram;;NIHSS score at 24 h;NIHSS score at 5–7 days;EQ-5D at 90 days;Asymptomatic intracerebral hemorrhage rate within 48 h;Incidence of extracranial hemorrhage complications (gastrointestinal hemorrhage, urethremorrhage, oral mucosa or nasal mucosa, ecchymoma, etc);Incidence of non-hemorrhagic severe adverse events (cerebral hernia, pneumonia, respiratory, circulatory, stress, secondary, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis, psychiatric symptoms, etc);Procedure and device related complications (arterial perforation, arterial dissection, failure to deploy, stent fracture, access-site complications, cerebral vasospasm, microcatheter dislocation, etc);Proportion of Rescue Drug utilization; | — |
Countries
China
Contacts
Public ContactQingwu Yang
Xinqiao Hospital, the Third Military Medical University
Outcome results
None listed