UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002216 |
|---|---|
| Receipt number | 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 14:28:11 |
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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
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
aaa-nagoya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Cardiology, Nagoya University Graduate School of Meidicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
