UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000172
Receipt number R000000027
Scientific Title ANTI-PLATELET THERAPY FOR COIL EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSMS
Date of disclosure of the study information 2005/09/12
Last modified on 2005/09/12 12:11:24

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Basic information

Public title

ANTI-PLATELET THERAPY FOR COIL EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSMS

Acronym

Japan ACE (Antiplatelet therapy for Coil Embolization) Trial

Scientific Title

ANTI-PLATELET THERAPY FOR COIL EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSMS

Scientific Title:Acronym

Japan ACE (Antiplatelet therapy for Coil Embolization) Trial

Region

Japan


Condition

Condition

Unruptured cerebral aneurysms

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The randomized clinical trial evaluating the effects of antiplatelet therapy for prevention of thromboembolic complications among patients undergoing endovascular treatments for unruptured intracranial aneurysms

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

All ischemic events or severe disability (including death) by another cause within a month

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

aspirin

Interventions/Control_2

no prescription

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. Modified Rankin Scale 0~2, 2. Aneurysms larger than 5mm in maximum diameter treated by simple tachnique, 3. First treatment case

Key exclusion criteria

1. Past history of cerebral infarction, ICH and SAH, 2. Patients already prescribed, antiplatelets and anticoagulants, 3. Patients with atherosclerotic diseases, 4. Patients with AVM, 5. Hemorrhagic tendency, 6. Aspirin allergy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Susumu Miyamoto

Organization

National Cardiovascular Center

Division name

Neurosurgery

Zip code


Address

5-7-1 Fujisirodai Suita, Osaka 565-8565 JAPAN

TEL

06-6833-5012

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Murao

Organization

National Cardiovascular Center

Division name

Neurosurgery

Zip code


Address

5-7-1 Fujisirodai Suita, Osaka 565-8565 JAPAN

TEL

06-6833-5012

Homepage URL


Email



Sponsor or person

Institute

National Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

Research grant from the Japanese Ministry of Health, Labor, and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2005 Year 09 Month 12 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

Date of protocol fixation

2004 Year 11 Month 09 Day

Date of IRB


Anticipated trial start date

2005 Year 01 Month 01 Day

Last follow-up date

2006 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 09 Month 12 Day

Last modified on

2005 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000027


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name