UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039875
Receipt number R000045473
Scientific Title Antiplatelet Therapy for NeuroEndovascular Therapy Retrospective Surveillance (ATHENS)
Date of disclosure of the study information 2020/03/19
Last modified on 2020/11/09 12:46:09

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Basic information

Public title

Antiplatelet Therapy for NeuroEndovascular Therapy Retrospective Surveillance (ATHENS)

Acronym

Antiplatelet Therapy for NeuroEndovascular Therapy Retrospective Surveillance (ATHENS)

Scientific Title

Antiplatelet Therapy for NeuroEndovascular Therapy Retrospective Surveillance (ATHENS)

Scientific Title:Acronym

Antiplatelet Therapy for NeuroEndovascular Therapy Retrospective Surveillance (ATHENS)

Region

Japan


Condition

Condition

cerebral aneurysm, cerebral artery stenosis

Classification by specialty

Neurology Radiology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate safety of endovascular treatment of intracranial aneurysm and cerebral artery stenosis during 15 months after treatment

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

schemic stroke during 15 months after endovascular treatment of intracranial aneurysm and cerebral artery stenosis

Key secondary outcomes

1 death and all stroke during 15 months after endovascular treatment of intracranial aneurysm and cerebral artery stenosis
2 hemorrhagic event during 15 months after endovascular treatment of intracranial aneurysm and cerebral artery stenosis


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 endovascular treatment of cerebral aneurysm and cerebral artery stenosis, treated between 2014/11/1 to 2016/10/31
2 20 year old or more at treatment
3 receive anti platelet treatment
4 received platelet coagulation examination
5 complete 6 moths follow up

Key exclusion criteria

ineligible patient for study by investigator decision

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Nobuyuki
Middle name
Last name Sakai

Organization

Kobe City Medical Center General Hospital

Division name

Neurosurgery

Zip code

650-0047

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan

TEL

078-302-4321

Email

n.sakai@siren.ocn.ne.jp


Public contact

Name of contact person

1st name Chiaki
Middle name
Last name Sakai

Organization

Kobe City Medical Center General Hospital

Division name

Center for Clinical Research and Innovation

Zip code

650-0047

Address

2-2 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan

TEL

078-302-4321

Homepage URL


Email

chiakimk@cronos.ocn.ne.jp


Sponsor or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



Funding Source

Organization

Kobe City Medical Center General Hospital

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

Kobe City Medical Center General Hospital

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan

Tel

078-302-4321

Email

rinken@kcho.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

広南病院(宮城県)、筑波大学(茨城県)、順天堂大学(東京都)、虎の門病院(東京都)、京都大学(京都府)、国立循環器病研究センター(大阪府)、兵庫医科大学(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、岡山大学(岡山県)


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 19 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

Open public recruiting

Date of protocol fixation

2019 Year 09 Month 21 Day

Date of IRB

2019 Year 09 Month 21 Day

Anticipated trial start date

2019 Year 09 Month 21 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 09 Month 30 Day

Date trial data considered complete

2021 Year 12 Month 31 Day

Date analysis concluded

2022 Year 06 Month 30 Day


Other

Other related information

Retrospective study of anti platelet therapy and related event of endovascular treatment of cerebral aneurysm and cerebral artery stenosis


Management information

Registered date

2020 Year 03 Month 19 Day

Last modified on

2020 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045473


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name