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 for these patients. The purpose of this study is to compare the safety and usefulness of prasugrel versus clopidogrel in patients who are scheduled to undergo stent or diverter treatment for non-ruptured cerebral aneurysms.
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 embolization with or without stent deployment and flow diverter insertion. However, these two techniques inevitably had the risk of thromboembolism. For prevention and decrease, dual antiplatelet therapy is commonly used in the clinical field. However, clopidogrel does not produce normal metabolites due to various internal and external factors in the metabolic process in the liver and eventually fails to perform its original role of platelet activity suppression in many situations, called "clopidogrel hyporesponsive". 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 for these patients. The purpose of this study is to compare the safety and usefulness of prasugrel versus clopidogrel in patients who are scheduled to undergo stent or diverter treatment for non-ruptured cerebral aneurysms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
406
Prescribe the drugs according to the assigned group, and take them 5 days before the procedure. Perform platelet function test (VerifyNow assay; Accumetrics, San Diego, California) one day before the procedure to check the P2Y12 reaction reactivity. And the hyporesponsive group patient is given prasugrel 5mg once. And aspirin 100mg and prasugrel 5mg will be maintained for 30 days.
Prescribe the drugs according to the assigned group, and take them 5 days before the procedure. Perform platelet function test (VerifyNow assay; Accumetrics, San Diego, California) one day before the procedure to check the P2Y12 reaction reactivity. And the hyporesponsive group patient is given pletaal 100mg once. And aspirin 100mg and clopidogrel 75mg mg will be maintained for 30 days.
Yongin Severance hospital, Yonsei university college of medicine
Gyeonggi-do, Yongin-si, South Korea
RECRUITINGperi-procedural thromboembolic complications
* thromboembolism detected during the neurointerventional procedure * transient ischemic attack or ischemic stroke or death with evidence of infarction on diffusion weighted imaging, which occurs within 30-days after procedure * incidence of treatment-thromboembolic, TIA and death events.
Time frame: 30 days
thromboembolic safety endpoint
* Ischemic stroke on relevant arterial territory within 30days after procedure or any stroke * Diffusion restriction lesion detected on post-procedure 7 days MRI * incidence of treatment-ischemic stroke on relevant territory and DWI lesion detected.
Time frame: 30days
bleeding safety endpoint
major and minor bleeding within 30days after procedure :: incidence of treatment-major and minor bleeding
Time frame: 30days
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