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Compares treatment options for Unruptured Intracranial Aneurysm
Official title INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT)
ClinicalTrials.gov ID: NCT07089862
What this study is testing
What is Indobufen treatment?
Indobufen treatment is an investigational medicine, given as an once-daily, being studied as a potential treatment for unruptured intracranial aneurysm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- Planned elective surgery within 3 months after the procedure;
- Any hematologic disorders or inherited coagulation abnormalities;
- Severe renal or hepatic dysfunction;
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.