Actively Recruiting
Indobufen Versus Aspirin in Endovascular Treatment of Unruptured Intracranial Aneurysms
Led by Beijing Tiantan Hospital · Updated on 2026-03-16
2500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of combining two antiplatelet drugs, indobufen and clopidogrel, to prevent blood clot-related events in patients undergoing endovascular treatment for unruptured intracranial aneurysms. This trial compares this combination with the standard treatment of aspirin plus clopidogrel. The goal is to see which regimen better prevents ischemic and bleeding complications after placing stents or flow diverters inside brain vessels. Patients with unruptured intracranial aneurysms scheduled for endovascular procedures will be randomly assigned to one of two groups. The experimental group will take indobufen (100 mg twice daily) plus clopidogrel (75 mg once daily), starting five days before the procedure and continuing for 180 days after surgery. The control group will receive aspirin (100 mg once daily) plus clopidogrel (75 mg once daily) on the same schedule. Treatment continues for six months post-procedure. Participants will be monitored for cerebrovascular thromboembolic events and bleeding events for up to 90 days after surgery. Researchers will also assess platelet function before surgery and track safety through bleeding classifications. The study involves regular follow-ups and evaluations to measure treatment effects on preventing clotting and bleeding complications after the vascular intervention, with the entire participation lasting at least six months.
CONDITIONS
Brief Title
INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Confirmed saccular intracranial aneurysm by specialist imaging assessment
- Scheduled for endovascular embolization including coil embolization with stent assistance or flow diversion
- Signed informed consent obtained
You will not qualify if you...
- Presence of other brain vascular malformations, tumors, abscesses, or diseases like multiple sclerosis
- Major surgery within 30 days before enrollment including fracture or hip replacement surgery
- History of ischemic stroke, ischemic heart disease, or hemorrhagic disorders including intracranial or gastrointestinal bleeding within past 6 months
- Planned elective surgery within 3 months after the procedure
- Hematologic disorders or inherited coagulation abnormalities
- Severe kidney or liver dysfunction
- History of bleeding disorders, thrombocytopenia, or neutropenia
- History of symptomatic non-traumatic brain hemorrhage or cerebral amyloid angiopathy
- Severe heart or lung diseases unsuitable for study
- Women of childbearing potential not using contraception, pregnant, or breastfeeding
- Currently participating in other investigational drug or device trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants start taking their assigned medication (indobufen plus clopidogrel or aspirin plus clopidogrel) 5 days before the endovascular procedure.
1 visit before the procedure
Duration - Up to 180 days postoperatively
Participants continue their assigned medication after the endovascular treatment of unruptured intracranial aneurysms to prevent thromboembolic events.
Multiple visits during treatment as per clinical protocol
Trial Site Locations
Total: 1 location
1
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Q
Qingyuan Liu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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