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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025884


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name