Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling
NCT ID: NCT05257824
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
528 participants
INTERVENTIONAL
2022-06-23
2025-12-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
2. long-term dual antiplatelet group: for 12 months
TREATMENT
NONE
Study Groups
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short-term dual antiplatelet group
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU \< 550 and PRU 85 \~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 6 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling
Aspirin 100mg
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months
2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
Clopidogrel 75mg
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months
2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
long-term dual antiplatelet group
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU \< 550 and PRU 85 \~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 12 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling.
Aspirin 100mg
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months
2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
Clopidogrel 75mg
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months
2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
Interventions
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Aspirin 100mg
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months
2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
Clopidogrel 75mg
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months
2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* subjects with modified Rankin Scale (mRS) ≤ 2
* subjects with unruptured intracranial aneurysms
* subjects with appropriated aspirin and clopidogrel reaction units after dual antiplatelet preparation (100 mg of aspirin and 75 mg of clopidogrel) for at least 5 days before procedure \[measured using VerifyNow\]
1. aspirin reaction unit (ARU) \< 550
2. P2Y12 reaction unit (PRU): 85\~219
* subjects who agreed to this study (with informed consent)
Exclusion Criteria
* subjects with an allergic reaction to antiplatelets (aspirin and clopidogrel) or contrast
* subjects with a high risk of hemorrhage such ICH or severe gastric ulceration
* subjects with coagulopathy
* subjects with thrombocytopenia (\<100,000/mm3)
* subjects with liver diseases (\> 100IU/L of aspartate aminotransferase or alanine aminotransferase)
* subjects with renal diseases (\> 2mg/dL of serum creatinine)
* subjects with underlying diseases that need to maintain dual antiplatelet drugs or anticoagulants.
* subjects with a high risk of strokes (atrial fibrillation, over 70% cerebral artery stenosis or cerebral artery occlusion, moyamoya disease, vascular malformations, etc)
* subjects with uncontrolled congestive heart failure or angina
* subjects with malignant tumors
* subjects with a positive pregnancy test (serum or urine)
* subjects who are unconscious at the time of diagnosis.
* subjects who are unable to complete the required follow-ups
* subjects with life-threatening diseases
* subjects with medical conditions with a life expectancy of less than two years
* subjects who are determined to be disqualified by researchers
19 Years
ALL
No
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Uijeongbu St. Mary's Hospital
UNKNOWN
Chungnam National University Sejong Hospital
OTHER
Soonchunhyang University Hospital
OTHER
Asan Medical Center
OTHER
Gangnam Severance Hospital, Yonsei University College of Medicine
UNKNOWN
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Kwon Oki
Professor
Principal Investigators
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O-Ki Kwon
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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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
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
Countries
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References
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UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
Hwang G, Kim JG, Song KS, Lee YJ, Villavicencio JB, Suroto NS, Park NM, Park SJ, Jeong EA, Kwon OK. Delayed ischemic stroke after stent-assisted coil placement in cerebral aneurysm: characteristics and optimal duration of preventative dual antiplatelet therapy. Radiology. 2014 Oct;273(1):194-201. doi: 10.1148/radiol.14140070. Epub 2014 Jun 11.
Hwang G, Huh W, Lee JS, Villavicencio JB, Villamor RB Jr, Ahn SY, Kim J, Chang JY, Park SJ, Park NM, Jeong EA, Kwon OK. Standard vs Modified Antiplatelet Preparation for Preventing Thromboembolic Events in Patients With High On-Treatment Platelet Reactivity Undergoing Coil Embolization for an Unruptured Intracranial Aneurysm: A Randomized Clinical Trial. JAMA Neurol. 2015 Jul;72(7):764-72. doi: 10.1001/jamaneurol.2015.0654.
Kim CH, Hwang G, Kwon OK, Ban SP, Chinh ND, Tjahjadi M, Oh CW, Bang JS, Kim T. P2Y12 Reaction Units Threshold for Implementing Modified Antiplatelet Preparation in Coil Embolization of Unruptured Aneurysms: A Prospective Validation Study. Radiology. 2017 Feb;282(2):542-551. doi: 10.1148/radiol.2016160542. Epub 2016 Sep 2.
Kim T, Kim CH, Kang SH, Ban SP, Kwon OK. Relevance of Antiplatelet Therapy Duration After Stent-Assisted Coil Embolization for Unruptured Intracranial Aneurysms. World Neurosurg. 2018 Aug;116:e699-e708. doi: 10.1016/j.wneu.2018.05.071. Epub 2018 May 17.
Hwang G, Jung C, Park SQ, Kang HS, Lee SH, Oh CW, Chung YS, Han MH, Kwon OK. Thromboembolic complications of elective coil embolization of unruptured aneurysms: the effect of oral antiplatelet preparation on periprocedural thromboembolic complication. Neurosurgery. 2010 Sep;67(3):743-8; discussion 748. doi: 10.1227/01.NEU.0000374770.09140.FB.
Almekhlafi MA, Al Sultan AS, Kuczynski AM, Brinjikji W, Menon BK, Hill MD, Goyal M. Antiplatelet therapy for prevention of thromboembolic complications in coiling-only procedures for unruptured brain aneurysms. J Neurointerv Surg. 2020 Mar;12(3):298-302. doi: 10.1136/neurintsurg-2019-015173. Epub 2019 Sep 20.
Other Identifiers
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B-2102-667-002
Identifier Type: -
Identifier Source: org_study_id