Indobufen versus aspirin plus clopidogrel for preventing clots after endovascular treatment of unruptured brain aneurysms

Indobufen Versus Aspirin in Endovascular Unruptured Intracranial Aneurysms Treatment

This trial will test whether taking indobufen with clopidogrel instead of aspirin with clopidogrel better prevents clotting or bleeding after stent-assisted coiling or flow-diverter treatment in adults with unruptured intracranial aneurysms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07089862 on ClinicalTrials.gov

What this trial studies

Adults with radiologically confirmed saccular unruptured intracranial aneurysms scheduled for endovascular treatment (stent-assisted coiling or flow diverter) will be randomized to receive either indobufen 100 mg twice daily plus clopidogrel 75 mg once daily or aspirin 100 mg once daily plus clopidogrel 75 mg once daily. Study drugs begin 5 days before the procedure and continue through 180 days after the procedure. Independent researchers will adjudicate cerebrovascular thromboembolic events and bleeding events at prespecified time points during follow-up. The design focuses on safety and efficacy of the antiplatelet regimens in the periprocedural and mid-term period after device-based aneurysm treatment.

Who should consider this trial

Good fit: Adults aged 18–75 with a radiologically confirmed saccular unruptured intracranial aneurysm scheduled for stent-assisted coiling or flow-diverter implantation who can take antiplatelet medications and provide informed consent are ideal candidates.

Not a fit: People with recent major bleeding, known bleeding or clotting disorders, recent stroke or significant cardiac ischemia, severe liver or kidney dysfunction, or other excluded cerebral diseases are unlikely to benefit and are excluded from participation.

Why it matters

Potential benefit: If successful, this regimen could lower the risk of ischemic complications or reduce bleeding compared with standard aspirin plus clopidogrel, improving outcomes after endovascular aneurysm treatment.

How similar studies have performed: Indobufen has shown antiplatelet effects and some favorable bleeding profiles in cardiology and other settings, but its use specifically for neuroendovascular aneurysm procedures is limited and this application is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Capital Medical University Affiliated Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Qingyuan Liu, M.D.

Conditions Unruptured Intracranial Aneurysm; Indobufen