UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000006100