UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005135 |
|---|---|
| Receipt number | R000006100 |
| Scientific Title | Small Unruptured Aneurysm Vertification-Prevention Effect Against Growth of Cerebral Aneurysm Study Using Statin |
| Date of disclosure of the study information | 2011/05/02 |
| Last modified on | 2019/06/04 17:02:35 |
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Basic information
Public title
Small Unruptured Aneurysm Vertification-Prevention Effect Against Growth of Cerebral Aneurysm Study Using Statin
Acronym
Small Unruptured Aneurysm Vertification-Prevention Effect Against Growth of Cerebral Aneurysm Study Using Statin
Scientific Title
Small Unruptured Aneurysm Vertification-Prevention Effect Against Growth of Cerebral Aneurysm Study Using Statin
Scientific Title:Acronym
Small Unruptured Aneurysm Vertification-Prevention Effect Against Growth of Cerebral Aneurysm Study Using Statin
Region
| Japan |
Condition
Condition
small unruptured cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to produce scientific evidence of the preventive effect of atorvastatin against progression and rupture of unruptured cerebral aneurysms and to establish the world's first medical treatment for them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
1)aneurysm enlargement over 0.5 mm
2)aneurysm morphological change (e.g., bleb formation)
3)rupture
Key secondary outcomes
cardiovascular events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
atorvastatin group: atorvastatin is administered at a daily dose of 10 mg for 3 years.
Interventions/Control_2
non-administration group
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) small unruptured cerebral saccular aneurysms (more than 3 mm and under 5 mm) diagnosed within 3 years from the date of registration.
2) aneurysms located in the circle of Willis or distal to the circle of Willis.
3) aneurysms are to be followed by MRA without surgical intervention after registration.
4) informed consent was obtained from the patient.
5) age of the patient is more than 20 and under 70 at the date of registration.
6) modified Rankin scale: 0~2
7) patients are capable of visiting out-patient clinic
Key exclusion criteria
1) comorbid untreated unruptured aneurysms larger than 5mm
2) within 6 months after direct/endovascular surgery for comorbid aneurysms
3) when comorbid surgically treated aneurysm is a giant aneurysm
4) patients with hyperlipidemia who need medical treatment
5) patients receiving fenofibrate
6) atorvastatin hypersensitivity
7) patients receiving anticoagulant or antithrombotic
8) patients with a history of intracerebral hemorrhage
9) patients with a history of cerebral infarct within 6 months
10) comorbid arteriovenous malformation
11) comorbid moyamoya disease
12) patients with severe hepatic dysfunction
13) alcohol intoxication
14) patient during pregnancy or lactation
15) medically uncontrolled hypertension
16) patient under treatment for malignancy
17) cardiac failure, myocardial infarction or unstable angina within 6 months
18) renal failure
19) respiratory failure
20) patients disqualified by the physician-in-charge
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Miyamoto |
Organization
Kyoto university, faculty of medicine
Division name
neurosurgery
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL
075-751-3653
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuimichi |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto university, faculty of medicine
Division name
neurosurgery
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL
075-751-3459
Homepage URL
http://neurosur.kuhp.kyoto-u.ac.jp/
pegasus@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of neurosurgery, faculty of medicine, Kyoto university
Institute
Department
Personal name
Funding Source
Organization
The Japan Neurosurgical Society
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital Ethics Committe
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
北海道大学 脳神経外科（北海道）、札幌医科大学 脳神経外科（北海道）、中村記念病院 脳神経外科（北海道）、岩手医科大学 脳神経外科（岩手県）、東北大学 脳神経外科（岩手県）、山形大学 脳神経外科（山形県）、新潟大学 脳神経外科（新潟県）、東京大学 脳神経外科（東京都）、杏林大学 脳神経外科（東京都）、東京女子医科大学 脳神経外科（東京都）、順天堂大学 脳神経外科（東京都）、NTT関東病院 脳神経外科（東京都）、北里大学 脳神経外科（神奈川県）、山梨大学 脳神経外科（山梨県）、信州大学 脳神経外科（長野県）、名古屋市立大学 脳神経外科（愛知県）、名古屋大学 脳神経外科（愛知県）、三重大学 脳神経外科（三重県）、岐阜大学 脳神経外科（岐阜県）、富山大学 脳神経外科（富山県）、金沢大学 脳神経外科（石川県）、滋賀医科大学 脳神経外科（滋賀県）、国循循環器病研究センター 脳血管外科（大阪府）、大阪大学 脳神経外科（大阪府）、城山病院 脳神経外科（大阪府）、松下記念病院 脳神経外科（大阪府）、京都大学 脳神経外科（京都府）、奈良県立医科大学 脳神経外科（奈良県）、神戸市立医療センター中央市民病院 脳神経外科（兵庫県）、大西脳神経外科（兵庫県）、姫路医療センター 脳神経外科（兵庫県）、岡山大学 脳神経外科（岡山県）、川崎医科大学 脳神経外科（岡山県）、倉敷中央病院 脳神経外科（岡山県）、広島大学 脳神経外科（広島県）、徳島大学 脳神経外科（徳島県）、山口大学 脳神経外科（山口県）、小倉記念病院 脳神経外科（福岡県）、九州大学 脳神経外科（福岡県）、福岡大学 脳神経外科（福岡県）、長崎大学 脳神経外科（長崎県）、長崎医療センター 脳神経外科（長崎県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 02 | 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
340
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under final analysis
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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 24 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006100
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| Registered date | File name |
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