Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

NCT03581409 | Completed Phase 4

• 1 other identifier: B-1712/439-001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Aneurysm, Cerebral; Endovascular Procedures

Keywords

antiplatelet preparation; cerebral aneurysm; coil embolization

Outcome Measures

Primary Outcomes (1)

• Incidence of hemorrhagic complications between 2 arms

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

  through study completion (for 3 months)

Secondary Outcomes (3)

• Change of the level of P2Y12

  through study completion (for 3 months)

• mortality between 2 arms

  through study completion (for 3 months)

• Incidence of thromboembolic complications between 2 arms

  through study completion (for 3 months)

Study Arms (2)

dual-antiplatelet

EXPERIMENTAL

Patients 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.

Drug: Aspirin; Drug: Prasugrel

triple-antiplatelet

EXPERIMENTAL

Patients 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.

Drug: Aspirin; Drug: Clopidogrel; Drug: Cilostazol

Interventions

Aspirin DRUG

Aspirin protect tablet

Also known as: Aspirin protect

dual-antiplatelet; triple-antiplatelet

Prasugrel DRUG

Prasugrel tablet

Also known as: Effient

dual-antiplatelet

Clopidogrel DRUG

Clopidogrel 75mg tablet

Also known as: Plavix, Plavitor

triple-antiplatelet

Cilostazol DRUG

Cilostazol tablet

Also known as: Pletaal, Cilostan CR

triple-antiplatelet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National Univeristy Bundang Hospital

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

Location

Related Publications (5)

• 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.

  PMID: 23886748 RESULT

• 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 RESULT

• 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.

  PMID: 24012432 RESULT

• 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 RESULT

• 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. 2025 Oct 10. doi: 10.1227/neu.0000000000003791. Online ahead of print.

  PMID: 41070954 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Aspirin; Prasugrel Hydrochloride; Clopidogrel; Cilostazol

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; Thiophenes; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tetrazoles; Azoles; Quinolines

Study Officials

• Seung Pil Ban, M.D.

  Seoul National Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 10, 2018
• Study Start: October 24, 2018
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: April 27, 2022

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)