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Recruitment status
Unique ID issued by UMIN C000000172
Receipt No. 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

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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
Institute National Cardiovascular Center
Institute
Department

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
URL(English) https://upload.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


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