UMIN-CTR Clinical Trial

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

Contact us.