Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

NCT05257824 | Completed Phase 4 DMC

• 1 other identifier: B-2102-667-002
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Aneurysm Cerebral; Endovascular Procedures

Keywords

dual antiplatelet; cerebral aneurysm; coil embolization; stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of periprocedural complications

  during procedure and within 1 month post-procedure

• Incidence of hemorrhagic complications

  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

  within 18 months post-procedure

• Incidence of unrelated complication with this study

  within 18 months post-procedure

• Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow

  at 6 months

Study Arms (2)

short-term dual antiplatelet group

ACTIVE COMPARATOR

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

Drug: Aspirin 100mg; Drug: Clopidogrel 75mg

long-term dual antiplatelet group

EXPERIMENTAL

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.

Drug: Aspirin 100mg; Drug: Clopidogrel 75mg

Interventions

Aspirin 100mg DRUG

1. short-term dual antiplatelet: dual antiplatelet agents for 6 months 2. long-term dual antiplatelet: dual antiplatelet agents for 12 months

Also known as: Aspirin protect, Aspirin enteric coated

long-term dual antiplatelet group; short-term dual antiplatelet group

Clopidogrel 75mg DRUG

1. short-term dual antiplatelet: dual antiplatelet agents for 6 months 2. long-term dual antiplatelet: dual antiplatelet agents for 12 months

Also known as: Plavix, Celavix, Plavitor, Pregrel, Cloart, Platless, Pidogle, Antipla, Jgrel

long-term dual antiplatelet group; short-term dual antiplatelet group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[measured using VerifyNow\]
• aspirin reaction unit (ARU) \< 550
• P2Y12 reaction unit (PRU): 85\~219
• subjects who agreed to this study (with informed consent)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Uijeongbu St. Mary's Hospital: collaborator
• Chungnam National University Sejong Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Asan Medical Center: collaborator
• Gangnam Severance Hospital, Yonsei University College of Medicine: collaborator
• Seoul National University Bundang Hospital: lead

Study Sites (8)

Chungnam National University Sejong Hospital

Sejong, Chungcheongnam-do, 30099, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Soonchunhyang University Seoul Hospital

Seoul, 04401, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Yonsei University Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Uijeongbu St. Mary's Hospital

Uijeongbu-si, 11765, South Korea

Location

Related Publications (7)

• 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.

  PMID: 22738097 BACKGROUND

• 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.

  PMID: 24918960 BACKGROUND

• 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.

  PMID: 26010803 BACKGROUND

• 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.

  PMID: 27603789 BACKGROUND

• 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.

  PMID: 29778598 BACKGROUND

• 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.

  PMID: 20651627 BACKGROUND

• 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.

  PMID: 31540948 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• O-Ki Kwon

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1. short-term dual antiplatelet group: for 6 months 2. long-term dual antiplatelet group: for 12 months

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 25, 2022
• Study Start: June 23, 2022
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)