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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005135
Receipt No. 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

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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
Email 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/
Email pegasus@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of neurosurgery, faculty of medicine, Kyoto university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006100

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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