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Aneurysm CerebralPhase 4NCT05257824

Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

A Phase 4 study testing Aspirin 100mg and Clopidogrel 75mg in people with Aneurysm Cerebral and Endovascular Procedures, run by Seoul National University Bundang Hospital at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Aneurysm Cerebral, Endovascular Procedures
What is being tested?
Aspirin 100mg and Clopidogrel 75mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
528 participants
Where
8 sitesSouth Korea
Study dates
23 Jun 2022to 2 Dec 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 42601

  • Chungnam National University Sejong Hospital

    Sejong, Chungcheongnam-do, 30099

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Soonchunhyang University Seoul Hospital

    Seoul, 04401

  • Asan Medical Center

    Seoul, 05505

  • Yonsei University Gangnam Severance Hospital

    Seoul, 06273

  • Uijeongbu St. Mary's Hospital

    Uijeongbu-si, 11765

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
Aspirin 100mg, Clopidogrel 75mg
Keywords
dual antiplatelet, cerebral aneurysm, coil embolization, stent
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspirin 100mgDrug

    Also called Aspirin protect, Aspirin enteric coated

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

  • Clopidogrel 75mgDrug

    Also called Plavix, Celavix, Plavitor, Pregrel

    1. short-term dual antiplatelet: dual antiplatelet agents for 6 months
    2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
Study groups in NCT05257824
Study groupRoleWhat they receive
short-term dual antiplatelet groupActive comparatorPatients 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
Receives: Drug: Aspirin 100mg; Drug: Clopidogrel 75mg
long-term dual antiplatelet groupExperimentalPatients 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.
Receives: Drug: Aspirin 100mg; Drug: Clopidogrel 75mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of thromboembolic complications

    The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure.

    Measured: between 1 and 18 months after stent-assisted coil embolization

Secondary outcomes (8)

  1. Incidence of periprocedural complications

    Incidence of periprocedural complications during procedure and within 1 month post-procedure

    Measured: during procedure and within 1 month post-procedure

  2. Incidence of hemorrhagic complications

    Incidence of hemorrhagic complications between 1 and 18 months post-procedure.

    Measured: between 1 and 18 months after stent-assisted coil embolization

  3. 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.

    Measured: within 18 months post-procedure

  4. Incidence of unrelated complication with this study

    Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study

    Measured: within 18 months post-procedure

  5. 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)

    Measured: at 6 months

  6. Periprocedural mortality

    Death within 1 month

    Measured: within 1 month

  7. Comparison of mortality

    Death between 1 and 18 months post-procedure

    Measured: between 1 and 18 months after stent-assisted coil embolization

  8. 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

    Measured: at 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start23 Jun 2022
  3. Primary completion2 Dec 2025
  4. Study completion2 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. short-term dual antiplatelet group: for 6 months 2. long-term dual antiplatelet group: for 12 months
Masking
None (open label)
Enrolment
528 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257824
Sponsor's protocol ID
B-2102-667-002
Status last verified
Dec 2025
First submitted
11 Feb 2022
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22738097

  • 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.

    PubMed 24918960

  • 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.

    PubMed 26010803

  • 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.

    PubMed 27603789

  • 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.

    PubMed 29778598

  • 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.

    PubMed 20651627

  • 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.

    PubMed 31540948

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin 100mg and Clopidogrel 75mg in people with Aneurysm Cerebral and Endovascular Procedures, run by Seoul National University Bundang Hospital at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of thromboembolic complications (time frame: between 1 and 18 months after stent-assisted coil embolization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05257824, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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