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Aneurysm, CerebralPhase 4NCT03581409

Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

A Phase 4 study testing Aspirin, Prasugrel and Clopidogrel in people with Aneurysm, Cerebral and Endovascular Procedures, run by Seoul National University Hospital at 1 site 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

Perform a randomized comparison study of dual-antiplatelet (aspirin, prasugrel) and triple-antiplatelet (aspirin, clopidogrel, and cilostazol) preparation using P2Y12 assay in patients with high on-treatment platelet reactivity undergoing stent-assisted coil embolization for an unruptured intracranial aneurysm Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Aneurysm, Cerebral, Endovascular Procedures
What is being tested?
Aspirin, Prasugrel and Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
1 siteSouth Korea
Study dates
24 Oct 2018to 22 Jan 2021
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patients with clopidogrel resistance (greater than 220 P2Y12 reaction units using VerifyNow)
  • patients with unruptured intracranial aneurysms
  • patients over 20 years old
  • patients who can communicate with each other
  • patients who agreed to this study (with informed consent)

Who cannot join

  • patients with recurrent aneurysms after coiling or clipping
  • patients with allergic reaction to antiplatelets
  • patients with high risks of hemorrhage
  • patients with coagulopathy
  • patients with thrombocytopenia (<100,000/mm3)
  • patients with liver disease (> 100 of aspartate aminotransferase or alanine aminotransferase)
Show all 12Show fewer
  • patients with renal disease (> 2mg/dL of serum creatinine)
  • patients with uncontrolled heart failure or angina
  • patients with malignant tumor
  • pregnant patients
  • patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor)
  • Patients who are determined to be disqualified by researchers

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National Univeristy Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

About this study

Official title: Comparison of Dual-Antiplatelet and Triple-Antiplatelet Preparation Using P2Y12 Assay in Patients With High On-Treatment Platelet Reactivity Undergoing Stent-Assisted Coil Embolization for An Unruptured Intracranial Aneurysm

Perform a randomized comparison study of dual-antiplatelet (aspirin, prasugrel) and triple-antiplatelet (aspirin, clopidogrel, and cilostazol) preparation using P2Y12 assay in patients with high on-treatment platelet reactivity undergoing stent-assisted coil embolization for an unruptured intracranial aneurysm

Read the detailed description

Comparison between dual-antiplatelet and triple-platelet preparation

Being tested
Aspirin, Prasugrel, Clopidogrel, Cilostazol
Keywords
antiplatelet preparation, cerebral aneurysm, coil embolization
Medical subject headings
Intracranial Aneurysm

What participants receive

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

  • AspirinDrug

    Also called Aspirin protect

    Aspirin protect tablet

  • PrasugrelDrug

    Also called Effient

    Prasugrel tablet

  • ClopidogrelDrug

    Also called Plavix, Plavitor

    Clopidogrel 75mg tablet

  • CilostazolDrug

    Also called Pletaal, Cilostan CR

    Cilostazol tablet

Study groups in NCT03581409
Study groupRoleWhat they receive
dual-antiplateletExperimentalPatients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received prasugrel 20mg. After that, dual-antiplatelet (aspirin 100mg \& prasugrel 5mg) treatment continued for 3 months through study completion.
Receives: Drug: Aspirin; Drug: Prasugrel
triple-antiplateletExperimentalPatients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion.
Receives: Drug: Aspirin; Drug: Clopidogrel; Drug: Cilostazol

What is being measured

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

  1. Incidence of hemorrhagic complications between 2 arms

    check minor and major hemorrhagic complications of intra- and post-procedures

    Measured: through study completion (for 3 months)

Secondary outcomes (3)

  1. Change of the level of P2Y12

    Check the change of the level of P2Y12 according to each arms during study periods

    Measured: through study completion (for 3 months)

  2. mortality between 2 arms

    check mortality after procedures

    Measured: through study completion (for 3 months)

  3. Incidence of thromboembolic complications between 2 arms

    check minor and major thromboembolic complications of intra- and post-procedures

    Measured: through study completion (for 3 months)

Timeline

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

  1. First posted10 Jul 2018
  2. Study start24 Oct 2018
  3. Primary completion22 Jan 2021
  4. Study completion22 Jan 2021

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
Masking
None (open label)
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03581409
Sponsor's protocol ID
B-1712/439-001
Status last verified
Oct 2019
First submitted
14 Jun 2018
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Geyik S, Yavuz K, Yurttutan N, Saatci I, Cekirge HS. Stent-assisted coiling in endovascular treatment of 500 consecutive cerebral aneurysms with long-term follow-up. AJNR Am J Neuroradiol. 2013 Nov-Dec;34(11):2157-62. doi: 10.3174/ajnr.A3574. Epub 2013 Jul 25.

    PubMed 23886748

  • 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

  • Park KH, Jeong MH, Lee KH, Sim DS, Yoon HJ, Yoon NS, Kim KH, Park HW, Hong YJ, Kim JH, Ahn Y, Cho JG, Park JC, Kang JC. Comparison of peri-procedural platelet inhibition with prasugrel versus adjunctive cilostazol to dual anti-platelet therapy in patients with ST segment elevation myocardial infarction. J Cardiol. 2014 Feb;63(2):99-105. doi: 10.1016/j.jjcc.2013.07.004. Epub 2013 Sep 5.

    PubMed 24012432

  • 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

  • Ban SP, Kwon OK, Kim YD, Shim HS, Sung SB, Bang JS, Lee SU, Lee SH, Choi TW, Park Y. Comparison of Triple Antiplatelet (Aspirin, Clopidogrel, and Cilostazol) and Modified Dual Antiplatelet (Aspirin and Low-Dose Prasugrel) Therapy in Patients With High On-Treatment Platelet Reactivity Undergoing Stent-Assisted Coil Embolization for an Unruptured Intracranial Aneurysm: A Prospective Randomized Clinical Trial. Neurosurgery. 2026 Jul 1;99(1):113-121. doi: 10.1227/neu.0000000000003791. Epub 2025 Oct 10.

    PubMed 41070954

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin, Prasugrel and Clopidogrel in people with Aneurysm, Cerebral and Endovascular Procedures, run by Seoul National University Hospital at 1 site 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 5 inclusion and 12 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 hemorrhagic complications between 2 arms (time frame: through study completion (for 3 months)). 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 NCT03581409, which also lists 5 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 27 Apr 2022.

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