UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022462 |
|---|---|
| Receipt number | R000025884 |
| Scientific Title | Dual AntiPlatelet Therapy for Stent Assisted Treatment of Cerebral Aneurysm |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2019/10/08 16:42:12 |
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Basic information
Public title
Dual AntiPlatelet Therapy for Stent Assisted Treatment of Cerebral Aneurysm
Acronym
DAPTS ACE
Scientific Title
Dual AntiPlatelet Therapy for Stent Assisted Treatment of Cerebral Aneurysm
Scientific Title:Acronym
DAPTS ACE
Region
| Japan |
Condition
Condition
intracranial aneurysm
Classification by specialty
| Hematology and clinical oncology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare safety of long dural anti platelet treatment (DAPT) following stent assisted embolization of intracranial aneurysm and short duration of DAPT,
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
ischemic stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm
Key secondary outcomes
1 death and all stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm
2 hemorrhagic event during 3 to 12 months after stent assisted embolization of intracranial aneurysm
3 death, stake and hemorrhagic event during 3 to 12 months after stent assisted embolization of intracranial aneurysm
4 pretreatment and stenosis or occlusion go stent during 3 to 12 months after stent assisted embolization of intracranial aneurysm
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
3 months dual anti platelet treatment following stent assisted embolization of intracranial aneurysm
Interventions/Control_2
12 months dual anti platelet treatment following stent assisted embolization of intracranial aneurysm
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 stent assisted embolization of intracranial aneurysm
2 receive aspirin and clopidogrel
3 20 year old or more
4 document informed consent
Key exclusion criteria
1 aute ruptured (within 14 days)
2 withdraw anti platelet treatment is scheduled during study
3 inappropriate for withdraw DAPT at 3 months
4 Platelet <100,000
5 need anti-coagulant treatment
6 intracranial hemorrhage or hemorrhagic tendency
Target sample size
300
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
0783024321
n.sakai@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nakagawa |
Organization
Translational Research Informatics
Division name
Project Management
Zip code
650-0047
Address
1-5-4 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
0783039108
Homepage URL
s-nakagawa@tri-kobe.org
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Translational Research Center for medical Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University
Address
Kusunoki cho 7-5-2, Chuo-ku, Kobe
Tel
078-382-6669
cerb@med.kobe-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
| 2016 | Year | 05 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025884
