Beijing Tiantan Hospital
Beijing, China
NCT Number: NCT06238115
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2 / Phase 3
Beijing, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: within 48 hours after procedure
Time frame: within 48 hours after procedure
Time frame: at postoperative 48-hour and 30-day
Time frame: at postoperative 48-hour and 30-day
Time frame: at postoperative 48-hour and 30-day
Time frame: at postoperative 48-hour and 30-day
Time frame: at postoperative 30-day
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 48-hour
Time frame: at postoperative 30-day
Time frame: at postoperative 48-hour and 30-day
Time frame: at postoperative 48-hour and 30-day
Time frame: at postoperative 48-hour and 30-day
Time frame: at postoperative 48-hour and 30-day
Beijing Tiantan Hospital
Other
Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms
Acronym: TEAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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