Unruptured Intracranial AneurysmNCT07089862
INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT)
A study testing Indobufen treatment and Aspirin treatment in people with Unruptured Intracranial Aneurysm and Indobufen, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Indobufen
- What is being tested?
- Indobufen treatment and Aspirin treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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);
- Postoperative life expectancy <3 months;
- Inability to complete 5-day premedication due to emergency surgery or other reasons;
- Intolerance to oral antiplatelet therapy due to allergy or other contraindications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
Qingyuan Liu, M.D., +86-13260457220, 13260457220@163.com
Shuo Wang, M.D.
About this study
Official title: 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.
- Conditions
- Unruptured Intracranial Aneurysm, Indobufen
- Being tested
- Indobufen treatment, Aspirin treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indobufen treatmentDrug
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 treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Aspirin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Within 90 days after endovascular treatment of unruptured intracranial aneurysms.
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: Within 24 hours before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start31 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089862
- Sponsor's protocol ID
- HX-B-2023016
- Status last verified
- Jun 2025
- First submitted
- 22 Jul 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indobufen Versus Aspirin in Endovascular Unruptured Intracranial Aneurysms Treatment
- ClinicalTrials.gov ID
- NCT07089862
- Acronym / sponsor ID
- HX-B-2023016
- Conditions
- Unruptured Intracranial Aneurysm, Indobufen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- 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
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indobufen+clopidogrel group | Experimental | Drug: Indobufen treatmentPatients 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 | Active comparator | Drug: Aspirin treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indobufen treatmentPatients 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+clopidogrel group |
| Aspirin treatmentPatients 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+clopidogrel group |
Primary outcome
Primary Efficacy Endpoint Events: Cerebrovascular thromboembolic events occurring within 90 days postoperatively
Time frame: within 90 days after endovascular treatment of unruptured intracranial aneurysms
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
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.
Time frame: 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.
3 secondary outcomes
Cerebrovascular thromboembolic events occurring within 30 days postoperatively
Time frame: Within 30 days postoperatively
Cerebrovascular thromboembolic events occurring within 180 days postoperatively
Time frame: Within 180 days postoperatively
Platelet aggregation rate within 24 hours before surgery
Time frame: Within 24 hours before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indobufen treatment and Aspirin treatment in people with Unruptured Intracranial Aneurysm and Indobufen, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingyuan Liu, M.D. (+86-13260457220, 13260457220@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint Events: Cerebrovascular thromboembolic events occurring within 90 days postoperatively (time frame: within 90 days after endovascular treatment of unruptured intracranial aneurysms). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.