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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Indobufen treatment
DrugPatients 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 treatment
DrugPatients 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.
Treatment groups
2,500 Participants
are divided into 2 treatment groupsGroup A: Indobufen+clopidogrel groupExperimental treatment 1 intervention
Group B: Aspirin+clopidogrel groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
within 90 days after endovascular treatment of unruptured intracranial aneurysms2
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.
Time frame
Within 90 days after endovascular treatment of unruptured intracranial aneurysms.Secondary outcomes
1
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
Time frame
Within 30 days postoperatively2
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
Time frame
Within 180 days postoperatively3
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.
Time frame
Within 24 hours before surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
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