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Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

Primary Purpose

Aneurysm Cerebral, Endovascular Procedures

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin 100mg
Clopidogrel 75mg
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subjects over 19 years old
  • subjects with modified Rankin Scale (mRS) ≤ 2
  • subjects with unruptured intracranial aneurysms

  • subjects with appropriated aspirin and clopidogrel reaction units after dual antiplatelet preparation (100 mg of aspirin and 75 mg of clopidogrel) for at least 5 days before procedure [measured using VerifyNow]

    1. aspirin reaction unit (ARU) < 550
    2. P2Y12 reaction unit (PRU): 85~219
  • subjects who agreed to this study (with informed consent)

Exclusion Criteria:

  • subjects with neurological deficits (mRS ≥ 3)
  • subjects with an allergic reaction to antiplatelets (aspirin and clopidogrel) or contrast
  • subjects with a high risk of hemorrhage such ICH or severe gastric ulceration
  • subjects with coagulopathy
  • subjects with thrombocytopenia (<100,000/mm3)
  • subjects with liver diseases (> 100IU/L of aspartate aminotransferase or alanine aminotransferase)
  • subjects with renal diseases (> 2mg/dL of serum creatinine)
  • subjects with underlying diseases that need to maintain dual antiplatelet drugs or anticoagulants.
  • subjects with a high risk of strokes (atrial fibrillation, over 70% cerebral artery stenosis or cerebral artery occlusion, moyamoya disease, vascular malformations, etc)
  • subjects with uncontrolled congestive heart failure or angina
  • subjects with malignant tumors
  • subjects with a positive pregnancy test (serum or urine)
  • subjects who are unconscious at the time of diagnosis.
  • subjects who are unable to complete the required follow-ups
  • subjects with life-threatening diseases
  • subjects with medical conditions with a life expectancy of less than two years
  • subjects who are determined to be disqualified by researchers

Sites / Locations

  • Soonchunhyang University Cheonan Hospital
  • Chungnam National University Sejong HospitalRecruiting
  • Soonchunhyang University Bucheon Hospital
  • Seoul National University Bundang HospitalRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • Keimyung University Dongsan Medical Center
  • Seoul National University Hospital
  • Severance Hospital
  • Soonchunhyang University Seoul Hospital
  • Asan Medical CenterRecruiting
  • Yonsei University Gangnam Severance HospitalRecruiting
  • Seoul St. Mary's Hospital
  • Ajou University Hospital
  • Uijeongbu St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

short-term dual antiplatelet group

long-term dual antiplatelet group

Arm Description

Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 6 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling

Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 12 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling.

Outcomes

Primary Outcome Measures

Incidence of thromboembolic complications
The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure.

Secondary Outcome Measures

Incidence of periprocedural complications
Incidence of periprocedural complications during procedure and within 1 month post-procedure
Incidence of hemorrhagic complications
Incidence of hemorrhagic complications between 1 and 18 months post-procedure.
Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up
Changes in clinical and functional outcomes at 18 months follow up, as measured by an increase in the modified Rankin Scale compared to baseline (modified Rankin Scale: 0) no symptoms, 1) able to carry out all usual activities, despite some symptoms, 2) able to look after own affairs without assistance, but unable to carry out all previous activities, 3) requires some help, but able to wal unassisted, 4) unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5) requires constant nursing care and attention, bedridden, incontinent and 6) dead.
Incidence of unrelated complication with this study
Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study
Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow
Change in aspirin reaction unit and P2Y12 reaction unit at the time of 6 months follow-up compared to baseline by using VerifyNow (Accumetrics, USA)
Periprocedural mortality
Death within 1 month
Comparison of mortality
Death between 1 and 18 months post-procedure
Changes in radiological outcomes by Roy-Raymond grades
Change in radiological outcomes at 18 months follow up compared to baseline as measured by Roy-Raymond grades: 1) complete, 2) residual neck, and 3) residual sac

Full Information

First Posted
February 11, 2022
Last Updated
June 29, 2023
Sponsor
Seoul National University Bundang Hospital
Collaborators
Soonchunhyang University Hospital, Seoul National University Hospital, Pusan National University Yangsan Hospital, Keimyung University Dongsan Medical Center, Seoul St. Mary's Hospital, Uijeongbu St. Mary's Hospital, Chungnam National University Sejong Hospital, Severance Hospital, Asan Medical Center, Yonsei University Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05257824
Brief Title
Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling
Official Title
Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling of Unruptured Intracranial Aneurysms: A Prospective Randomized Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Soonchunhyang University Hospital, Seoul National University Hospital, Pusan National University Yangsan Hospital, Keimyung University Dongsan Medical Center, Seoul St. Mary's Hospital, Uijeongbu St. Mary's Hospital, Chungnam National University Sejong Hospital, Severance Hospital, Asan Medical Center, Yonsei University Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms
Detailed Description
The purpose of this study is to compare the incidence of thromboembolic and hemorrhagic complications between 1 and 18 months after stent-assisted coiling according to the duration of use of dual antiplatelet agents (6 months versus 12 months) after stent-assisted coiling of unruptured intracranial aneurysms to determine the optimal duration of use of dual antiplatelet agents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm Cerebral, Endovascular Procedures
Keywords
dual antiplatelet, cerebral aneurysm, coil embolization, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
short-term dual antiplatelet group: for 6 months long-term dual antiplatelet group: for 12 months
Masking
None (Open Label)
Allocation
Randomized
Enrollment
528 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
short-term dual antiplatelet group
Arm Type
Active Comparator
Arm Description
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 6 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling
Arm Title
long-term dual antiplatelet group
Arm Type
Experimental
Arm Description
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 12 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling.
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg
Other Intervention Name(s)
Aspirin protect, Aspirin enteric coated
Intervention Description
short-term dual antiplatelet: dual antiplatelet agents for 6 months long-term dual antiplatelet: dual antiplatelet agents for 12 months
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 75mg
Other Intervention Name(s)
Plavix, Celavix, Plavitor, Pregrel, Cloart, Platless, Pidogle, Antipla, Jgrel
Intervention Description
short-term dual antiplatelet: dual antiplatelet agents for 6 months long-term dual antiplatelet: dual antiplatelet agents for 12 months
Primary Outcome Measure Information:
Title
Incidence of thromboembolic complications
Description
The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure.
Time Frame
between 1 and 18 months after stent-assisted coil embolization
Secondary Outcome Measure Information:
Title
Incidence of periprocedural complications
Description
Incidence of periprocedural complications during procedure and within 1 month post-procedure
Time Frame
during procedure and within 1 month post-procedure
Title
Incidence of hemorrhagic complications
Description
Incidence of hemorrhagic complications between 1 and 18 months post-procedure.
Time Frame
between 1 and 18 months after stent-assisted coil embolization
Title
Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up
Description
Changes in clinical and functional outcomes at 18 months follow up, as measured by an increase in the modified Rankin Scale compared to baseline (modified Rankin Scale: 0) no symptoms, 1) able to carry out all usual activities, despite some symptoms, 2) able to look after own affairs without assistance, but unable to carry out all previous activities, 3) requires some help, but able to wal unassisted, 4) unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5) requires constant nursing care and attention, bedridden, incontinent and 6) dead.
Time Frame
within 18 months post-procedure
Title
Incidence of unrelated complication with this study
Description
Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study
Time Frame
within 18 months post-procedure
Title
Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow
Description
Change in aspirin reaction unit and P2Y12 reaction unit at the time of 6 months follow-up compared to baseline by using VerifyNow (Accumetrics, USA)
Time Frame
at 6 months
Title
Periprocedural mortality
Description
Death within 1 month
Time Frame
within 1 month
Title
Comparison of mortality
Description
Death between 1 and 18 months post-procedure
Time Frame
between 1 and 18 months after stent-assisted coil embolization
Title
Changes in radiological outcomes by Roy-Raymond grades
Description
Change in radiological outcomes at 18 months follow up compared to baseline as measured by Roy-Raymond grades: 1) complete, 2) residual neck, and 3) residual sac
Time Frame
at 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects over 19 years old subjects with modified Rankin Scale (mRS) ≤ 2 subjects with unruptured intracranial aneurysms subjects with appropriated aspirin and clopidogrel reaction units after dual antiplatelet preparation (100 mg of aspirin and 75 mg of clopidogrel) for at least 5 days before procedure [measured using VerifyNow] aspirin reaction unit (ARU) < 550 P2Y12 reaction unit (PRU): 85~219 subjects who agreed to this study (with informed consent) Exclusion Criteria: subjects with neurological deficits (mRS ≥ 3) subjects with an allergic reaction to antiplatelets (aspirin and clopidogrel) or contrast subjects with a high risk of hemorrhage such ICH or severe gastric ulceration subjects with coagulopathy subjects with thrombocytopenia (<100,000/mm3) subjects with liver diseases (> 100IU/L of aspartate aminotransferase or alanine aminotransferase) subjects with renal diseases (> 2mg/dL of serum creatinine) subjects with underlying diseases that need to maintain dual antiplatelet drugs or anticoagulants. subjects with a high risk of strokes (atrial fibrillation, over 70% cerebral artery stenosis or cerebral artery occlusion, moyamoya disease, vascular malformations, etc) subjects with uncontrolled congestive heart failure or angina subjects with malignant tumors subjects with a positive pregnancy test (serum or urine) subjects who are unconscious at the time of diagnosis. subjects who are unable to complete the required follow-ups subjects with life-threatening diseases subjects with medical conditions with a life expectancy of less than two years subjects who are determined to be disqualified by researchers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Pil Ban
Phone
82-31-787-7175
Email
neurosurgeryban@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
O-Ki Kwon
Phone
82-31-787-7163
Email
meurokwonoki@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
O-Ki Kwon
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan
State/Province
Chungcheongnam-do
ZIP/Postal Code
31151
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Sang Oh
Email
metatron1324@hotmail.com
Facility Name
Chungnam National University Sejong Hospital
City
Sejong
State/Province
Chungcheongnam-do
ZIP/Postal Code
30099
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung Soo Byoun
Email
prettypig9@hanmail.net
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bum-Tae Kim
Email
bumtkim@gmail.com
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Pil Ban
Phone
82-31-787-7175
Email
neurosurgeryban@gmail.com
First Name & Middle Initial & Last Name & Degree
O-Ki Kwon
Phone
82-31-787-7163
Email
meurokwonoki@gmail.com
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Hyeun Kim
Phone
82-55-360-2556
Email
mole83@naver.com
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Hyun Kim
Email
ppori2k@gmail.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Min Kim
Email
quintus@hotmail.co.kr
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Jae Kim, MD
Email
jungjaekim.ns@gmail.com
Facility Name
Soonchunhyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sukh Que Park
Email
drcolor@schmc.ac.kr
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Cheol Park
Email
neurosg@gmail.com
Facility Name
Yonsei University Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Kyu Park, MD
Email
skparkns@yuhs.ac
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jai Ho Choi
Email
bivalvia98@gmail.com
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Cheol Lim
Email
nsyclim@gmail.com
Facility Name
Uijeongbu St. Mary's Hospital
City
Uijeongbu
ZIP/Postal Code
11765
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Woo Kim
Email
nsman9802@naver.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22738097
Citation
UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
Results Reference
background
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
background
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
background
PubMed Identifier
27603789
Citation
Kim CH, Hwang G, Kwon OK, Ban SP, Chinh ND, Tjahjadi M, Oh CW, Bang JS, Kim T. P2Y12 Reaction Units Threshold for Implementing Modified Antiplatelet Preparation in Coil Embolization of Unruptured Aneurysms: A Prospective Validation Study. Radiology. 2017 Feb;282(2):542-551. doi: 10.1148/radiol.2016160542. Epub 2016 Sep 2.
Results Reference
background
PubMed Identifier
29778598
Citation
Kim T, Kim CH, Kang SH, Ban SP, Kwon OK. Relevance of Antiplatelet Therapy Duration After Stent-Assisted Coil Embolization for Unruptured Intracranial Aneurysms. World Neurosurg. 2018 Aug;116:e699-e708. doi: 10.1016/j.wneu.2018.05.071. Epub 2018 May 17.
Results Reference
background
PubMed Identifier
20651627
Citation
Hwang G, Jung C, Park SQ, Kang HS, Lee SH, Oh CW, Chung YS, Han MH, Kwon OK. Thromboembolic complications of elective coil embolization of unruptured aneurysms: the effect of oral antiplatelet preparation on periprocedural thromboembolic complication. Neurosurgery. 2010 Sep;67(3):743-8; discussion 748. doi: 10.1227/01.NEU.0000374770.09140.FB.
Results Reference
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PubMed Identifier
31540948
Citation
Almekhlafi MA, Al Sultan AS, Kuczynski AM, Brinjikji W, Menon BK, Hill MD, Goyal M. Antiplatelet therapy for prevention of thromboembolic complications in coiling-only procedures for unruptured brain aneurysms. J Neurointerv Surg. 2020 Mar;12(3):298-302. doi: 10.1136/neurintsurg-2019-015173. Epub 2019 Sep 20.
Results Reference
background

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Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

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