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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Qingyuan Liu, M.D.
• Email: 13260457220@163.com
• Phone: +86-13260457220

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting unruptured brain aneurysm rupture risk with blood pressure variability and 3D changes

  This study follows adults with unruptured intracranial aneurysms who are managed without surgery to see if blood pressure variability and 3D changes in the aneurysm can predict rupture risk using advanced AI.

  Recruiting Beijing Tiantan Hospital · Beijing · NCT07893574

• Early complications after flow diverter versus stent-assisted coiling for unruptured wide-neck intracranial bifurcation aneurysms

  This real-world study tests which endovascular treatment—flow diverter or stent-assisted coiling—has fewer early complications in adults with unruptured wide-neck bifurcation aneurysms.

  Recruiting at 3 sites Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong and 2 other locations · NCT07754188

• Gentle ear vagus nerve stimulation to reduce headache after aneurysm stent coiling

  This study will try a noninvasive ear vagus nerve stimulation device to see if it reduces postoperative headaches in adults having stent-assisted coiling or flow-diverter treatment for unruptured brain aneurysms.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07479082

• Comparing protein patterns in extracellular vesicles from different blood vessels in people with ruptured or unruptured brain aneurysms

  This project tries to see if protein differences in extracellular vesicles taken from different blood vessels can help diagnose or predict outcomes for people with ruptured or unruptured brain aneurysms undergoing neurointerventional procedures.

  Recruiting The First Hospital of Jilin University · Changchun, Jilin · NCT07439965

• Clinical and economic impact of Sim&Size 3D simulation for planning implants in unruptured intracranial aneurysms

  This trial will test whether using Sim&Size 3D simulation software to plan implantable devices reduces complications, procedure time, radiation exposure, and costs for adults having endovascular treatment of unruptured intracranial aneurysms.

  Recruiting at 3 sites Sim&Cure · Angers and 5 other locations · NCT07433075

• Evaluating a new embolization system for unruptured brain aneurysms

  This study is testing a new device to see if it can safely treat unruptured brain aneurysms in patients.

  Recruiting at 5 sites LuSeed Vascular LTD. · Sofia and 5 other locations · NCT06761365

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.