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Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

Primary Purpose

Aneurysm, Cerebral, Endovascular Procedures

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Aspirin

Prasugrel

Clopidogrel

Cilostazol

About this trial

This is an interventional treatment trial for Aneurysm, Cerebral focused on measuring antiplatelet preparation, cerebral aneurysm, coil embolization

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Seoul National Univeristy Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

dual-antiplatelet

triple-antiplatelet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of hemorrhagic complications between 2 arms

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

Secondary Outcome Measures

Change of the level of P2Y12

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

mortality between 2 arms

check mortality after procedures

Incidence of thromboembolic complications between 2 arms

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

Full Information

NCT ID

NCT03581409

First Posted

June 14, 2018

Last Updated

April 19, 2022

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03581409

Brief Title

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

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

October 24, 2018 (Actual)

Primary Completion Date

January 22, 2021 (Actual)

Study Completion Date

January 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aneurysm, Cerebral, Endovascular Procedures

Keywords

antiplatelet preparation, cerebral aneurysm, coil embolization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

198 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dual-antiplatelet

Arm Type

Experimental

Arm Description

Arm Title

triple-antiplatelet

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Aspirin

Other Intervention Name(s)

Aspirin protect

Intervention Description

Aspirin protect tablet

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Other Intervention Name(s)

Effient

Intervention Description

Prasugrel tablet

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Plavix, Plavitor

Intervention Description

Clopidogrel 75mg tablet

Intervention Type

Drug

Intervention Name(s)

Cilostazol

Other Intervention Name(s)

Pletaal, Cilostan CR

Intervention Description

Cilostazol tablet

Primary Outcome Measure Information:

Title

Incidence of hemorrhagic complications between 2 arms

Description

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

Time Frame

through study completion (for 3 months)

Secondary Outcome Measure Information:

Title

Change of the level of P2Y12

Description

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

Time Frame

through study completion (for 3 months)

Title

mortality between 2 arms

Description

check mortality after procedures

Time Frame

through study completion (for 3 months)

Title

Incidence of thromboembolic complications between 2 arms

Description

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

Time Frame

through study completion (for 3 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seung Pil Ban, M.D.

Organizational Affiliation

Seoul National Bundang Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Seoul National Univeristy Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23886748

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.

Results Reference

result

PubMed Identifier

26010803

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.

Results Reference

result

PubMed Identifier

24012432

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.

Results Reference

result

PubMed Identifier

24918960

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.

Results Reference

result

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Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

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