Clinical trial NCT03581409: Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aneurysm, Cerebral
Endovascular Procedures
Keywords: antiplatelet preparation
cerebral aneurysm
coil embolization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2018-07-10
Enrollment: 198
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Comparison between dual-antiplatelet and triple-platelet preparation

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of hemorrhagic complications between 2 arms
timeFrame: through study completion (for 3 months)
Secondary outcomes:
measure: Change of the level of P2Y12
timeFrame: through study completion (for 3 months)
measure: mortality between 2 arms
timeFrame: through study completion (for 3 months)
measure: Incidence of thromboembolic complications between 2 arms
timeFrame: through study completion (for 3 months)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univeristy Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National Bundang Hospital
name: Seung Pil Ban, M.D.
role: STUDY_CHAIR
References:
citation: 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.
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.
citation: 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.
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.