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RECRUITING

NCT07089862

INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT)

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

Official title: Indobufen Versus Aspirin in Endovascular Unruptured Intracranial Aneurysms Treatment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2025-08-31

Completion Date

2026-12-31

Last Updated

2026-03-16

Healthy Volunteers

Conditions

Unruptured Intracranial Aneurysm Indobufen

Interventions

DRUG

Indobufen treatment

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.

DRUG

Aspirin treatment

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.

Inclusion Criteria: 1. Age 18-75 years (male or female); 2. Radiologically confirmed saccular intracranial aneurysm (by specialist assessment); 3. Scheduled for endovascular embolization (including: coil embolization with stent assistance or flow diversion); 4. Signed informed consent obtained. Exclusion Criteria: 1. Concomitant vascular malformations, tumors, abscesses or other cerebral diseases such as multiple sclerosis; 2. Major surgery within 30 days prior to enrollment including fracture surgery or hip replacement; 3. History of ischemic stroke, ischemic heart disease or hemorrhagic disorders including intracranial hemorrhage, gastrointestinal bleeding, fundus hemorrhage or unexplained bleeding within the past 6 months; 4. Planned elective surgery within 3 months after the procedure; 5. Any hematologic disorders or inherited coagulation abnormalities; 6. Severe renal or hepatic dysfunction; 7. History of hemostatic disorders, systemic bleeding, thrombocytopenia or neutropenia; 8. History of symptomatic non-traumatic intracranial hemorrhage or cerebral amyloid angiopathy; 9. Severe cardiopulmonary diseases considered by investigators to be unsuitable for the study; 10. Women of childbearing potential with negative pregnancy test but refusing contraceptive measures, or those who are pregnant or lactating; 11. Current participation in other investigational drug or device trials. Withdrawal Criteria: 1. Receiving aneurysm treatment other than coil embolization with stent assistance or flow diversion; 2. Occurrence of endpoint events during stent-assisted aneurysm embolization procedure (as adjudicated by the Clinical Events Committee), including procedure-related hemorrhagic events (aneurysm rupture, parent artery rupture, subarachnoid hemorrhage, acute ipsilateral intracerebral hemorrhage, and acute ipsilateral subdural/epidural hematoma) or ischemic events (acute large vessel occlusion, in-stent thrombosis, and diffuse ipsilateral vascular infarction caused by plaque dislodgement); 3. Device-related quality issues during stent-assisted embolization, including stent problems (stent fracture, failure to deploy properly, incomplete expansion due to product defect) and coil problems (premature detachment before intentional deployment, coil unraveling, and failure to detach); 4. Postoperative life expectancy \<3 months; 5. Inability to complete 5-day premedication due to emergency surgery or other reasons; 6. Intolerance to oral antiplatelet therapy due to allergy or other contraindications.

Locations (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China