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
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
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
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
