Comparing prasugrel and clopidogrel for treating unruptured brain aneurysms
Low-dose Prasgurel Versus Clopidogrel on the Dual Antiplatelet Regimen for Intracranial Stenting or Flow Diverter Treatment for Unruptured Cerebral Aneurysms: a Multi-center Randomized Controlled Trial
This study is testing whether a new blood thinner called prasugrel works better and is safer than clopidogrel for people with unruptured brain aneurysms who are getting treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 406 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Gyeonggi-do, Yongin-si) |
| Trial ID | NCT05359224 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of low-dose prasugrel compared to clopidogrel in patients undergoing stenting or flow diversion for unruptured intracranial aneurysms. Given that a significant portion of the population may not respond adequately to clopidogrel, leading to increased thromboembolism risk, prasugrel is being investigated as a potentially better alternative. Participants will be monitored for outcomes related to thromboembolic events and overall treatment efficacy. The study will include patients who have consented and meet specific eligibility criteria regarding their aneurysm status and treatment plans.
Who should consider this trial
Good fit: Ideal candidates are patients with unruptured intracranial aneurysms scheduled for stenting or flow diverter treatment.
Not a fit: Patients with a history of acute ischemic stroke, recent intracranial hemorrhage, or those on other antiplatelet medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective antiplatelet therapy option for patients undergoing treatment for unruptured brain aneurysms.
How similar studies have performed: Other studies have indicated that prasugrel may be a more effective option than clopidogrel for certain patient populations, suggesting a promising avenue for this investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * UIAs without any evidence of rupture in intracranial imaging study within the last 6 months * Planned treatment with coil embolization with stent insertion or flow diverter insertion * If the patient himself/herself consented to this study Exclusion Criteria: * ∙ History of acute ischemic stroke or transient ischemic attack * Any intracranial hemorrhage except subarachnoid hemorrhage due to aneurysm rupture within the last 3 months * Concurrent treatment other than endovascular procedure (e.g. open craniotomy and microsurgical clipping) * Contraindications to iodine contrast agents * Already taking antiplatelet drugs or antithrombotic drugs other than aspirin * Hypersensitivity to aspirin, prasugrel or clopidogrel * Cardiac arrhythmia that should be needed to take anticoagulants * Pregnancy or lactating * Chronic kidney disease (\< GFR 60) * Patients with chronic liver disease who have at least over 100 IU/L of either AST/ALT in the liver function test * Patients with pathological active bleeding, such as peptic ulcer * Patients with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption because they contain lactose * Patients continuously taking non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 inhibitors * Patients requiring concomitant administration of methotrexate 15 mg or more for one week * If it is judged difficult to follow up after treatment
Where this trial is running
Gyeonggi-do, Yongin-si
- Yongin Severance hospital, Yonsei university college of medicine — Gyeonggi-do, Yongin-si, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Chang Ki Jang
- Email: changgeejang@yuhs.ac
- Phone: 82-031-5189-8484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.