Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms
The purpose of this study is to compare the incidence of thromboembolic and hemorrhagic complications between 1 and 18 months after stent-assisted coiling according to the duration of use of dual antiplatelet agents (6 months versus 12 months) after stent-assisted coiling of unruptured intracranial aneurysms to determine the optimal duration of use of dual antiplatelet agents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
528
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months 2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months 2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
Chungnam National University Sejong Hospital
Sejong, Chungcheongnam-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Keimyung University Dongsan Medical Center
Incidence of thromboembolic complications
The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure.
Time frame: between 1 and 18 months after stent-assisted coil embolization
Incidence of periprocedural complications
Incidence of periprocedural complications during procedure and within 1 month post-procedure
Time frame: during procedure and within 1 month post-procedure
Incidence of hemorrhagic complications
Incidence of hemorrhagic complications between 1 and 18 months post-procedure.
Time frame: between 1 and 18 months after stent-assisted coil embolization
Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up
Changes in clinical and functional outcomes at 18 months follow up, as measured by an increase in the modified Rankin Scale compared to baseline (modified Rankin Scale: 0) no symptoms, 1) able to carry out all usual activities, despite some symptoms, 2) able to look after own affairs without assistance, but unable to carry out all previous activities, 3) requires some help, but able to wal unassisted, 4) unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5) requires constant nursing care and attention, bedridden, incontinent and 6) dead.
Time frame: within 18 months post-procedure
Incidence of unrelated complication with this study
Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study
Time frame: within 18 months post-procedure
Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow
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Daegu, South Korea
Soonchunhyang University Seoul Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Yonsei University Gangnam Severance Hospital
Seoul, South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Change in aspirin reaction unit and P2Y12 reaction unit at the time of 6 months follow-up compared to baseline by using VerifyNow (Accumetrics, USA)
Time frame: at 6 months
Periprocedural mortality
Death within 1 month
Time frame: within 1 month
Comparison of mortality
Death between 1 and 18 months post-procedure
Time frame: between 1 and 18 months after stent-assisted coil embolization
Changes in radiological outcomes by Roy-Raymond grades
Change in radiological outcomes at 18 months follow up compared to baseline as measured by Roy-Raymond grades: 1) complete, 2) residual neck, and 3) residual sac
Time frame: at 18 months