Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

Endovascular Procedures Clinical Trial

Official title:

Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling of Unruptured Intracranial Aneurysms: A Prospective Randomized Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257824
• Other study ID #: B-2102-667-002
• Status: Recruiting
• Phase: Phase 4
• Start date: June 23, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Seoul National University Bundang Hospital
• Contact: Seung Pil Ban
• Phone: 82-31-787-7175
• Email: neurosurgeryban[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 528
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Cerebral
• Endovascular Procedures

Intervention

Drug:
• Aspirin 100mg
short-term dual antiplatelet: dual antiplatelet agents for 6 months long-term dual antiplatelet: dual antiplatelet agents for 12 months
• Clopidogrel 75mg
short-term dual antiplatelet: dual antiplatelet agents for 6 months long-term dual antiplatelet: dual antiplatelet agents for 12 months

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan	Chungcheongnam-do
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong	Chungcheongnam-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do

Sponsors (11)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Asan Medical Center, Chungnam National University Sejong Hospital, Keimyung University Dongsan Medical Center, Pusan National University Yangsan Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, Severance Hospital, Soonchunhyang University Hospital, Uijeongbu St. Mary's Hospital, Yonsei University Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of thromboembolic complications	The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure.	between 1 and 18 months after stent-assisted coil embolization
Secondary	Incidence of periprocedural complications	Incidence of periprocedural complications during procedure and within 1 month post-procedure	during procedure and within 1 month post-procedure
Secondary	Incidence of hemorrhagic complications	Incidence of hemorrhagic complications between 1 and 18 months post-procedure.	between 1 and 18 months after stent-assisted coil embolization
Secondary	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.	within 18 months post-procedure
Secondary	Incidence of unrelated complication with this study	Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study	within 18 months post-procedure
Secondary	Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow	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)	at 6 months
Secondary	Periprocedural mortality	Death within 1 month	within 1 month
Secondary	Comparison of mortality	Death between 1 and 18 months post-procedure	between 1 and 18 months after stent-assisted coil embolization
Secondary	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	at 18 months