NCT06238115

Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unruptured Intracranial Aneurysm
• Flow Diverter
• Stent-assisted Coiling
• Thromboembolic Events

Interventions

Type	Name	Description
DRUG	Tirofiban	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.
DRUG	aspirin, clopidogrel	aspirin 100 mg/day, clopidogrel 75 mg/day

Timeline

• Start date: 2024-03-04
• Primary completion: 2025-10-09
• Completion: 2025-11-09
• First posted: 2024-02-02
• Last updated: 2025-12-11

Locations

1 site across 1 country: China