Overview
To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.
Description
This is a single-center, open-label, assessor-blinded randomized controlled trial. Participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: Tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. Placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (DWI) within 48 hours after procedure.
Eligibility
Inclusion Criteria:
- Ages 18-80.
- Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.
- Completement of preoperative antiplatelet preparation.
- Signed informed consent.
Exclusion Criteria:
- Abnormal platelet count (normal reference is 100-300×10^9/L).
- Allergy to study drugs and anesthetics.
- Contradictory to MRI examination.
- Known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm).
- Known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months.
- Clear indications for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).
- Antiplatelet drug (exclude aspirin and clopidogrel) being taken within 72 hours; anticoagulant drug (including heparin or oral anticoagulants) being taken within 10 days;
- Participants with recurrent aneurysms who have received neurointerventional treatment.
- Inability to follow endovascular procedures due to anatomical difficulties.
- Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST > twice the upper limit of normal range) insufficiency.
- Severe heart failure (NYHA classes III and IV) or severe arrhythmias, including sick sinus syndrome, severe atrioventricular block, and bradycardia-related syncope.
- Pregnant.