ow-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
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006700
- Lead Sponsor
- Yonsei University Yongin Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 406
? A healthy adult of Korean nationality aged 19 or over and under 75 years of age
? If a non-ruptured cerebral aneurysm without bleeding within the last 6 months is confirmed by imaging
? If treatment is planned with a stent or blood flow diverter
? When the patient himself/herself consented to this study
? In case of rupture within the last 6 months
? In case of bleeding requiring treatment including intracranial hemorrhage within the last 3 months
? If you have already been treated
? In case of concurrent treatment other than endovascular procedure
? Contraindications to iodine contrast agents
? If you are already taking antiplatelet drugs or antithrombotic drugs other than aspirin
? In case of hypersensitivity to aspirin, prasgurel or clopidogrel
? In the event that an arrhythmia or blood clot in the heart is detected and antithrombotic medication is required
? Pregnant or lactating
? Kidney failure below GFR 60
? Patients with chronic liver disease with at least 100 IU/L of either AST/ALT in the liver function test
? If it is judged difficult to follow up after treatment
? Patients with pathological active bleeding such as peptic ulcer
? Patients with lactose-containing genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
? Patients requiring concomitant administration of methotrexate 15 mg or more for one week.
? Patients with a history of stroke or transient ischemic attack (TIA)
-Patients continuously taking non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 inhibitors
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Thromboembolism occurred during treatment and any stroke and death for 30 days of treatment
- Secondary Outcome Measures
Name Time Method MR DWI (+) lesions performed within 7 days of treatment, platelet function test value (PRU) and antiplatelet adjustment ratio