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
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
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
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
