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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
192
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.
aspirin 100 mg/day, clopidogrel 75 mg/day
Beijing Tiantan Hospital
Beijing, China
The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
Time frame: within 48 hours after procedure
The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
Time frame: within 48 hours after procedure
Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure.
Time frame: at postoperative 48-hour and 30-day
Incidence of ischemic stroke within 48-hour and 30-day after procedure.
Time frame: at postoperative 48-hour and 30-day
Incidence of transient ischemic attack within 48-hour and 30-day after procedure.
Time frame: at postoperative 48-hour and 30-day
Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure.
Time frame: at postoperative 48-hour and 30-day
Disabling stroke within 30-day after procedure.
Disabling stroke is defined as modified Rankin Scale score \>1. The modified Rankin Scale score ranges from 0 to 6, and the higher the score, the greater the degree of disability.
Time frame: at postoperative 30-day
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