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Indobufen Versus Aspirin in Endovascular Unruptured Intracranial Aneurysms Treatment

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This project aims to evaluate the safety and efficacy of the antiplatelet regimen combining indobufen and clopidogrel in preventing ischemic events after stent-assisted coiling embolization and flow diverter implantation for intracranial aneurysms. Using a randomization system, patients with unruptured intracranial aneurysms scheduled for interventional treatment will be divided into an experimental group and a control group. Patients in the experimental group will be required to take indobufen (100 mg twice daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively. Patients in the control group will be required to take aspirin (100 mg once daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively. An independent group of researchers will assess cerebrovascular thromboembolic events and bleeding events at different time points.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75 years (male or female);

• Radiologically confirmed saccular intracranial aneurysm (by specialist assessment);

• Scheduled for endovascular embolization (including: coil embolization with stent assistance or flow diversion);

• Signed informed consent obtained.

Locations
Other Locations
China
Capital Medical University Affiliated Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Qingyuan Liu, M.D.
13260457220@163.com
+86-13260457220
Time Frame
Start Date: 2025-08-31
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2500
Treatments
Experimental: Indobufen+clopidogrel group
Patients in the experimental group will be required to take indobufen (100 mg twice daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively.
Active_comparator: Aspirin+clopidogrel group
Patients in the control group will be required to take aspirin (100 mg once daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively.
Related Therapeutic Areas
Sponsors
Collaborators: RenJi Hospital, Beijing Shuyi Hospital, Beijing Friendship Hospital, Beijing Chao Yang Hospital, Jiangnan University Central Hospital, First Affiliated Hospital of Fujian Medical University, The Central Hospital of Lishui City
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov