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

Official title

Indobufen Versus Aspirin in Endovascular Unruptured Intracranial Aneurysms Treatment

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Primary Efficacy Endpoint Events: Cerebrovascular thromboembolic events occurring within 90 days postoperatively [Time frame: 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. [Time frame: Within 90 days after endovascular treatment of unruptured intracranial aneurysms.]

Secondary outcome measures (3)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Capital Medical University Affiliated Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT07089862 · HX-B-2023016

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗