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RecruitingNCT07089862Updated Mar 16, 2026

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

An interventional study of Indobufen treatment and Aspirin treatment in Unruptured Intracranial Aneurysm and Indobufen, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
2,500
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Unruptured Intracranial Aneurysm
  • Indobufen
03

In context

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,500 participants (estimated)

Study arms

  • 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.

    Drug: Indobufen treatment

  • 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.

    Drug: Aspirin treatment

Interventions

  • DrugIndobufen 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.

  • DrugAspirin 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.

06

What researchers measure

Primary outcomes

  1. Primary Efficacy Endpoint Events: Cerebrovascular thromboembolic events occurring within 90 days postoperatively

    Cerebrovascular thromboembolic events within 90 days after endovascular treatment of unruptured intracranial aneurysms, including: Ischemic stroke, Transient ischemic attack (TIA), Stent thrombosis, Emergency revascularization, Cerebrovascular death

    Time frame: within 90 days after endovascular treatment of unruptured intracranial aneurysms

  2. Primary Safety Endpoint Events: Incidence of bleeding events classified as Type 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) criteria within 90 days after endovascular treatment of unruptured intracranial aneurysms.

    Bleeding events classified as Type 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) criteria within 90 days after endovascular treatment of unruptured intracranial aneurysms.

    Time frame: Within 90 days after endovascular treatment of unruptured intracranial aneurysms.

Secondary outcomes

  1. Cerebrovascular thromboembolic events occurring within 30 days postoperatively

    Cerebrovascular thromboembolic events within 30 days after endovascular treatment of unruptured intracranial aneurysms, including: Ischemic stroke, Transient ischemic attack (TIA), Stent thrombosis, Emergency revascularization, Cerebrovascular death

    Time frame: Within 30 days postoperatively

  2. Cerebrovascular thromboembolic events occurring within 180 days postoperatively

    Cerebrovascular thromboembolic events within 180 days after endovascular treatment of unruptured intracranial aneurysms, including: Ischemic stroke, Transient ischemic attack (TIA), Stent thrombosis, Emergency revascularization, Cerebrovascular death

    Time frame: Within 180 days postoperatively

  3. Platelet aggregation rate within 24 hours before surgery

    Platelet aggregation rate within 24 hours before surgery, including ADP-induced platelet aggregation, Collagen-induced platelet aggregation and Arachidonic acid-induced platelet aggregation.

    Time frame: Within 24 hours before surgery

07

Study locations

1 of 1 sites recruiting
  • Capital Medical University Affiliated Beijing Tiantan Hospital
    Beijing, Beijing Municipality, China
    • Qingyuan Liu, M.D. · Contact · 13260457220@163.com · +86-13260457220
    • Shuo Wang, M.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07089862
Lead sponsor
Beijing Tiantan Hospital
Collaborators
RenJi Hospital, First Affiliated Hospital of Fujian Medical University, Jiangnan University Central Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Shuyi Hospital, The Central Hospital of Lishui City
Responsible party
Wang Shuo (Director of Department of Cerebrovascular Neurosurgery, Beijing Tiantan Hospital) — Principal investigator
First posted
Jul 28, 2025
Start date
Aug 31, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 16, 2026

Study contacts

Qingyuan Liu, M.D.
Contact
13260457220@163.com
+86-13260457220

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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