UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044122
Receipt number R000050384
Scientific Title Antiplatelet therapy in endovascular treatment for intracranial aneurysms, a multi center cohort study (APT-ANswer study)
Date of disclosure of the study information 2021/05/06
Last modified on 2023/11/06 21:33:17

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Basic information

Public title

Antiplatelet therapy in endovascular treatment for intracranial aneurysms, a multi center cohort study (APT-ANswer study)

Acronym

Antiplatelet therapy in endovascular treatment for intracranial aneurysms, a multi center cohort study (APT-ANswer study)

Scientific Title

Antiplatelet therapy in endovascular treatment for intracranial aneurysms, a multi center cohort study (APT-ANswer study)

Scientific Title:Acronym

Antiplatelet therapy in endovascular treatment for intracranial aneurysms, a multi center cohort study (APT-ANswer study)

Region

Japan


Condition

Condition

Antiplatelet therapy in neck-remodeling device-assiste d endovascular treatment for intracranial aneurysms, a multi center cohort study
Antiplatelet therapy in neck-remodeling device-assiste d endovascular treatment for intracranial aneurysms, a multi center cohort study
Antiplatelet therapy in neck-remodeling device-assiste d endovascular treatment for intracranial aneurysms, a multi center cohort study
Antiplatelet therapy in neck-remodeling device-assiste d endovascular treatment for intracranial aneurysms, a multi center cohort study
unruptured intracranial aneurysm

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarify the optimal regimen of antiplatelet therapy in endovascular treatment for cerebral aneurysms

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes


Time from endovascular treatment to onset of thromb oembolic events related to target vessels, or death

Key secondary outcomes


1) hemorrhagic events equivalent to ISTH major bleed ing
2) hemorrhagic events which required intervention by a medical professional
3) asymptomatic ischemic lesion on MRI-DWI
4) Ischemic event other than cerebrovascular disease


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with unruptured cerebral aneurysm over 20 years old
2) Patients who received stent-assisted neuroendovasc ular treatment for unruptured cerebral aneurysm from January 1, 2010 to December 31, 2020.
3) Patients who received periprocedural dual antiplate let therapy

Key exclusion criteria

(1) Patients who could not receive sufficient preoperati ve antiplatelet therapy due to emergency treatment for ruptured cerebral aneurysm, symptomatic cerebral an eurysm, etc.
(2) In addition, patients who are judged to be inappro priate as targets by the judgment of the investigator.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Yukiko
Middle name
Last name Enomoto

Organization

Gifu Univeristy Graduate School of Medicine

Division name

Neurosurgery

Zip code

5011194

Address

1-1 Yanagido, Gifu city, GIFU

TEL

058-230-6271

Email

enomoto@gifu-u.ac.jp


Public contact

Name of contact person

1st name Hirofumi
Middle name
Last name Matsubara

Organization

Gifu Univeristy Graduate School of Medicine

Division name

Neurosurgery

Zip code

501-1194

Address

1-1 Yanagido, Gifu city, GIFU

TEL

058-230-6271

Homepage URL


Email

neuro_s@gifu-u.ac.jp


Sponsor or person

Institute

Gifu University

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gifu Univeristy IRB

Address

1-1 Yanagido, Gifu city, GIFU

Tel

05802306059

Email

rinri@gifu-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 04 Month 09 Day

Date of IRB

2021 Year 04 Month 07 Day

Anticipated trial start date

2021 Year 05 Month 05 Day

Last follow-up date

2021 Year 10 Month 30 Day

Date of closure to data entry

2021 Year 10 Month 30 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2023 Year 05 Month 31 Day


Other

Other related information

The patients underwent endovascular treatment during 2010.1.1~2020.12.31 will be included.

Observe all event that occurred from endovascular treatment to the most recent observation


Management information

Registered date

2021 Year 05 Month 06 Day

Last modified on

2023 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050384


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name