UMIN-CTR Clinical Trial

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
Institute	Kobe City Medical Center General Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045473