Acute ischemic stroke
Conditions
Interventions
Intervention group:Intra-arterial Bolus Administration of Tirofiban Followed by Intravenous Tirofiban Infusion after Endovascular Treatment
Control group:Intra-arterial Bolus of Normal Saline Followed by Intravenous Tirofiban after Endovascular Treatment
Sponsors
The First Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Time from symptom onset to randomization within 24 hours; 3. A preliminary diagnosis of ischemic stroke with a non-cardiogenic embolic etiology based on patient history, clinical symptoms, or imaging findings; 4. National Institutes of Health Stroke Scale (NIHSS) score >= 6; 5. Alberta Stroke Program Early CT Score (ASPECTS) >= 3; 6. Occlusion of the internal carotid artery, M1/M2 segment of the middle cerebral artery (MCA), vertebral artery, or basilar artery confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA), with a decision to proceed with endovascular treatment; 7. Achievement of successful vascular recanalization (modified Thrombolysis in Cerebral Infarction [mTICI] grade 2-3) following endovascular treatment, with the decision for adjunctive balloon angioplasty or stent placement left to the operator's discretion; 8. Absence of PH-type hemorrhagic transformation on immediate post-procedural head CT (or CT-like imaging from the DSA system); 9. Provision of written informed consent by the patient or legal guardian.
Exclusion criteria
Exclusion criteria: 1. A history of documented atrial fibrillation or atrial flutter, or atrial flutter or atrial fibrillation confirmed by 12-lead electrocardiogram (ECG) prior to randomization and after admission; 2. Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI), or a history of hemorrhage within the past month; 3. A pre-stroke modified Rankin Scale (mRS) score > 2, or use of medications that increase bleeding risk within one week, including dual antiplatelet therapy, direct oral anticoagulants (DOACs), or warfarin; 4. Participation in other clinical trials or inability to complete follow-up; 5. Allergy to the study drugs or contrast agents; pregnancy or lactation; uncontrolled hypertension; hemorrhagic diathesis; deficiency of anticoagulant factors or an international normalized ratio (INR) > 1.7; abnormal blood glucose; platelet count < 90×10?/L; 6. Severe renal insufficiency, or a terminal illness with a life expectancy < 6 months; 7. Intracranial aneurysm or arteriovenous malformation; arterial tortuosity precluding thrombectomy; space-occupying brain tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of mRS score in 90 (±7) days;90 (±7) days mRs 0-3 ratio;Proportion of symptomatic intracranial hemorrhage within 24 (-6/+24) hours after treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90 (±7) days mRs 0-1 ratio;90 (±7) days mRs 0-2 ratio;Changes of NIHSS score 5-7 days after operation or at discharge;90 days (±7) EQ-5D-3L scale score;The number of cases in which tirofiban was discontinued due to bleeding during intra-arterial administration;Incidence ratio of cerebral parenchymal hemorrhage types (PH1) and (PH2) after 24 hours of treatment (-6/+24);The proportion of serious adverse events within 24 (-6/+24) hours of treatment;The proportion of all-cause deaths within 7 days of treatment (or earlier); | — |
Countries
China
Contacts
Public ContactShaoshuai Wang
The First Hospital of Shanxi Medical University
Outcome results
None listed