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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002216
Receipt No. R000002639
Scientific Title AAA<aortic aneurismal remodeling by ARB> Study
Date of disclosure of the study information 2009/07/16
Last modified on 2014/06/25

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Basic information
Public title AAA<aortic aneurismal remodeling by ARB> Study
Acronym AAA<aortic aneurismal remodeling by ARB> Study
Scientific Title AAA<aortic aneurismal remodeling by ARB> Study
Scientific Title:Acronym AAA<aortic aneurismal remodeling by ARB> Study
Region
Japan

Condition
Condition abdominal aortic aneurysm
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the pleiotropic effect(s) of ARB on remodeling of preoperative abdominal aortic aneurysm in comparison to that of CCB.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes changes in the maximum diameter of abdominal aortic aneurysm measured on the short axis
Key secondary outcomes MACE, mortality, number of surgery, circulating biomarkers,
PWI/ABI, carotid arterial intimal thickness, cardiac diastolic function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 AAA patients who is treated with ARB for 2 years
Interventions/Control_2 AAA patients who is treated with CCB for 2 years
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria AAA patients complicated with hypertension whose maximum short axis diameter of AAA is ranged from more than 3.0cm to less than 4.5cm.
aged more than 40years old
male
menopausal female
AAA patients with surgical indication who is preferred to medical control and/or who have been considered as inoperative.
Key exclusion criteria female who is pregnant and supposed to be pregnant.
coronary spastic angina patients who is treated with calcium channel blocker.
malignancy
patients who refused the cooperation for this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoaki Murohara
Organization Nagoya University Graduate School of Meidicine
Division name Cardiology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2196
Email aaa-nagoya@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Bando
Organization Nagoya University Graduate School of Meidicine
Division name Cardiology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2196
Homepage URL http://www.AAA-nagoya.com
Email aaa-nagoya@med.nagoya-u.ac.jp

Sponsor
Institute Cardiology, Nagoya University Graduate School of Meidicine
Institute
Department

Funding Source
Organization Nagoya University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Saiseikai Kumamoto Hospital
Name of secondary funder(s) Vascular Surgery, Nagoya University Graduate School of Meidicine

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 名古屋大学医学部附属病院(愛知県)、
名古屋大学循環器内科・血管外科関連病院(愛知県・岐阜県・三重県・静岡県)
済生会熊本病院(熊本県)

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 16 Day

Related information
URL releasing protocol http://www.AAA-nagoya.com
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 No longer recruiting
Date of protocol fixation
2009 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 09 Month 30 Day
Date analysis concluded
2017 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 16 Day
Last modified on
2014 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002639

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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