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

NCT ID: NCT07089862

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Indobufen treatment

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Aspirin treatment

Intervention Type: 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.

Interventions

Indobufen 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.

Intervention Type: DRUG

Aspirin 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Jiangnan University Central Hospital

UNKNOWN

Sponsor Role: collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

Beijing Shuyi Hospital

OTHER

Sponsor Role: collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Shuo

Director of Department of Cerebrovascular Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HX-B-2023016

Identifier Type: -

Identifier Source: org_study_id