Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

Endovascular Procedures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581409
• Other study ID #: B-1712/439-001
• Status: Completed
• Phase: Phase 4
• Start date: October 24, 2018
• Est. completion date: January 22, 2021

Study information

• Verified date: October 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Description:

Comparison between dual-antiplatelet and triple-platelet preparation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Cerebral
• Endovascular Procedures
• Intracranial Aneurysm

Intervention

Drug:
• Aspirin
Aspirin protect tablet
• Prasugrel
Prasugrel tablet
• Clopidogrel
Clopidogrel 75mg tablet
• Cilostazol
Cilostazol tablet

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univeristy Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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 Ju — View 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 Reactivi — View 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 th — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of the level of P2Y12	Check the change of the level of P2Y12 according to each arms during study periods	through study completion (for 3 months)
Secondary	mortality between 2 arms	check mortality after procedures	through study completion (for 3 months)
Secondary	Incidence of thromboembolic complications between 2 arms	check minor and major thromboembolic complications of intra- and post-procedures	through study completion (for 3 months)