INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Indobufen treatment
- Aspirin treatment
Treatment groups
2,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
RenJi Hospital
Collaborator
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
Source ClinicalTrials.gov