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

NCT07089862 | Recruiting DMC

• 1 other identifier: HX-B-2023016
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unruptured Intracranial Aneurysm; Indobufen

Outcome Measures

Primary Outcomes (2)

• 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

  within 90 days after endovascular treatment of unruptured intracranial aneurysms

• 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.

  Within 90 days after endovascular treatment of unruptured intracranial aneurysms.

Secondary Outcomes (3)

• Cerebrovascular thromboembolic events occurring within 30 days postoperatively

  Within 30 days postoperatively

• Cerebrovascular thromboembolic events occurring within 180 days postoperatively

  Within 180 days postoperatively

• Platelet aggregation rate within 24 hours before surgery

  Within 24 hours before surgery

Study Arms (2)

Indobufen+clopidogrel group

EXPERIMENTAL

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

Aspirin+clopidogrel group

ACTIVE COMPARATOR

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

Indobufen treatment DRUG

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.

Indobufen+clopidogrel group

Aspirin treatment DRUG

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.

Aspirin+clopidogrel group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years (male or female);
• Radiologically confirmed saccular intracranial aneurysm (by specialist assessment);
• Scheduled for endovascular embolization (including: coil embolization with stent assistance or flow diversion);
• Signed informed consent obtained.

You may not qualify if:

• Concomitant vascular malformations, tumors, abscesses or other cerebral diseases such as multiple sclerosis;
• Major surgery within 30 days prior to enrollment including fracture surgery or hip replacement;
• 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;
• Planned elective surgery within 3 months after the procedure;
• Any hematologic disorders or inherited coagulation abnormalities;
• Severe renal or hepatic dysfunction;
• History of hemostatic disorders, systemic bleeding, thrombocytopenia or neutropenia;
• History of symptomatic non-traumatic intracranial hemorrhage or cerebral amyloid angiopathy;
• Severe cardiopulmonary diseases considered by investigators to be unsuitable for the study;
• Women of childbearing potential with negative pregnancy test but refusing contraceptive measures, or those who are pregnant or lactating;
• Current participation in other investigational drug or device trials.
• Withdrawal Criteria:
• Receiving aneurysm treatment other than coil embolization with stent assistance or flow diversion;
• 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);
• 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);

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: collaborator
• Jiangnan University Central Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Beijing Shuyi Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• Beijing Tiantan Hospital: lead
• RenJi Hospital: collaborator

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Qingyuan Liu, M.D.

CONTACT

+86-13260457220; 13260457220@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 28, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-06

Locations

CN (1)