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

Indobufen Versus Aspirin in Endovascular Unruptured Intracranial Aneurysms Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Unruptured Intracranial Aneurysm; Indobufen
• Intervention / Treatment: Drug: Indobufen treatment; Drug: Aspirin treatment

• Study Type: Interventional
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qingyuan Liu, M.D.; Phone Number: +86-13260457220; Email: 13260457220@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Capital Medical University Affiliated Beijing Tiantan Hospital
      • Principal Investigator: Shuo Wang, M.D.
      • Contact: Qingyuan Liu, M.D.; Phone Number: +86-13260457220; Email: 13260457220@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 30 days postoperatively
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	Within 180 days postoperatively
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.	Within 24 hours before surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 22, 2025
• First Submitted That Met QC Criteria: July 22, 2025
• First Posted (Actual): July 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Aspirin; Indobufen
• Other Study ID Numbers: HX-B-2023016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No