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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002635
Receipt No. R000003212
Scientific Title Synergy Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Open Label Randomized Trial-
Date of disclosure of the study information 2009/10/17
Last modified on 2011/04/15

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Basic information
Public title Synergy Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Open Label Randomized Trial-
Acronym The Joetsu Aortic Plaques Prevention Trial
Scientific Title Synergy Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Open Label Randomized Trial-
Scientific Title:Acronym The Joetsu Aortic Plaques Prevention Trial
Region
Japan

Condition
Condition Hyperlipidemia, Diabetes, Hypertension
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Regression of thoracic aortic plaques by statins was demonstrated. However, because of differences between the property of abdominal aortic plaque and thoracic aortic plaque, the regression effects on abdominal aortic plaque have not been observed. We aimed to determine whether the combination treatment of statin and bisphosphonate was more effective than statin or bisphosphonate treatment in regression of aortic plaques.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The changing rate (%) of hyperplasia in Maximal Wall Thickness after one year
...ATR + ETD group vs. of ATR group
Key secondary outcomes The changing rate (%) of hyperplasia in Maximal Wall Thickness after one year
...ATR + ETD group vs. of ETD group
The changing rate (%) of Total Vascular Area and Lumen Area
The changing rate (%) of LDLchol value
...ATR + ETD group vs. ATR group,
ATR + ETD group vs. ETD group

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Atorvastatin + Etidronate (ATR+ETD) group
November 2009-March 2011
Interventions/Control_2 Atorvastatin (ATR) group
November 2009-March 2011
Interventions/Control_3 Etidronate (ETD) group
November 2009-March 2011
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
30 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Pulse Wave Velocity &#8805; 1800
carotid artery echo: plaque score &#8805; 3
200 &#8805; LDL cholesterol &#8805; 160mg/dl
Not take an improving drug of lipid metabolism for 3 months. Not take an improving drug of osteoporosis for 3 months
Bone Mineral Density > -1SD
Key exclusion criteria The patients who have psychic disturbance, Collagen disease, liver renal dysfunction, heart disorder, cerebrovascular disorder, and or serious complications. The patients who were decided that participation is inappropriate for them by chief physician.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Kawahara
Organization Niigata-Rousai Hospital
Division name Internal Medicine
Zip code
Address 1-7-12, Touncho, Joetsu-shi, Niigata, Japan
TEL 025-543-3123
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Kawahara
Organization Niigata-Rousai Hospital
Division name Internal Medicine
Zip code
Address 1-7-12, Touncho, Joetsu-shi, Niigata, Japan
TEL 025-543-3123
Homepage URL http://www.niigatah.rofuku.go.jp/
Email k-tetsuy@niirou.jp

Sponsor
Institute Niigata-Rousai Hospital
Institute
Department

Funding Source
Organization Niigata-Rousai Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor National Institute of Public Health
Name of secondary funder(s)

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 新潟労災病院(新潟県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 17 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
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 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 17 Day
Last modified on
2011 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003212

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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