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

Launched by BEIJING TIANTAN HOSPITAL · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different medicine combinations used to prevent blood clots after a specific treatment for unruptured brain aneurysms. A brain aneurysm is a weak spot in a blood vessel that can bulge and sometimes cause problems. The treatment involves placing tiny devices inside the blood vessels to block off the aneurysm and prevent it from bursting. The trial compares a newer drug called indobufen combined with clopidogrel against the more commonly used aspirin combined with clopidogrel, to see which combination is safer and better at preventing strokes or bleeding after the procedure.

Adults aged 18 to 75 with a diagnosed unruptured brain aneurysm who are scheduled for this type of treatment may be eligible to join. Participants will take either indobufen plus clopidogrel or aspirin plus clopidogrel starting five days before their procedure and continuing for six months afterward. Throughout the study, doctors will carefully monitor for any issues like blood clots or bleeding. People with certain health problems, recent major surgeries, or bleeding disorders may not qualify. This study is not yet recruiting, but it aims to find out if indobufen can be a safe and effective alternative to aspirin in helping patients recover from aneurysm treatment.

Gender

ALL

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.