UMIN-CTR Clinical Trial

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
Email	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
Email	s-nakagawa@tri-kobe.org

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025884