Status:
UNKNOWN
Low Dose Prasugrel vs Clopidogrel for Stenting or Flow Diverter for Unruptured Aneurysm
Lead Sponsor:
Yonsei University
Collaborating Sponsors:
Severance Hospital
Gangnam Severance Hospital
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
19-75 years
Phase:
PHASE4
Brief Summary
Low clopidogrel response has been reported in about 5-44% of the total population, which is associated with an increase in thromboembolism. Recently prasugrel drug widely accepted as a good option fo...
Detailed Description
Unruptured intracranial aneurysm (UIA) is a relatively common disease with a prevalence of about 1% of the total population. Widely accepted techniques of neuro-interventional therapy are coil emboliz...
Eligibility Criteria
Inclusion
- 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
- ∙ 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT05359224
Start Date
June 13 2022
End Date
August 1 2025
Last Update
July 15 2022
Active Locations (1)
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1
Yongin Severance hospital, Yonsei university college of medicine
Gyeonggi-do, Yongin-si, South Korea, 16995