Clinical trial NCT05257824: Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling
Official title: Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling of Unruptured Intracranial Aneurysms: A Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Aneurysm Cerebral
Endovascular Procedures
Keywords: dual antiplatelet
cerebral aneurysm
coil embolization
stent
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Pusan National University Yangsan Hospital
name: Keimyung University Dongsan Medical Center
name: Uijeongbu St. Mary's Hospital
name: Chungnam National University Sejong Hospital
name: Soonchunhyang University Hospital
name: Asan Medical Center
name: Gangnam Severance Hospital, Yonsei University College of Medicine
First posted: 2022-02-25
Enrollment: 528
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. short-term dual antiplatelet group: for 6 months
2. long-term dual antiplatelet group: for 12 months
Primary purpose: TREATMENT

Brief summary: Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* subjects over 19 years old
* 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 neurological deficits (mRS ≥ 3)
* 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

Primary outcomes:
measure: Incidence of thromboembolic complications
timeFrame: between 1 and 18 months after stent-assisted coil embolization
Secondary outcomes:
measure: Incidence of periprocedural complications
timeFrame: during procedure and within 1 month post-procedure
measure: Incidence of hemorrhagic complications
timeFrame: between 1 and 18 months after stent-assisted coil embolization
measure: Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up
timeFrame: within 18 months post-procedure
measure: Incidence of unrelated complication with this study
timeFrame: within 18 months post-procedure
measure: Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow
timeFrame: at 6 months
measure: Periprocedural mortality
timeFrame: within 1 month
measure: Comparison of mortality
timeFrame: between 1 and 18 months after stent-assisted coil embolization
measure: Changes in radiological outcomes by Roy-Raymond grades
timeFrame: at 18 months
Other outcomes:
Locations:
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
state: Chungcheongnam-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Gangnam Severance Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: O-Ki Kwon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.