UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003756 |
|---|---|
| Receipt number | R000004551 |
| Scientific Title | Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Prospective Open Label Trial- |
| Date of disclosure of the study information | 2010/06/15 |
| Last modified on | 2010/11/05 09:00:29 |
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Basic information
Public title
Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Prospective Open Label Trial-
Acronym
Aortic Plaques Prevention Trial by Etidronate and Atorvastatin
Scientific Title
Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Prospective Open Label Trial-
Scientific Title:Acronym
Aortic Plaques Prevention Trial by Etidronate and Atorvastatin
Region
| Japan |
Condition
Condition
Hyperlipidemia, Diabetes, Hypertension, Osteoporosis
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
Not applicable
Assessment
Primary outcomes
The changing rate (%) of hyperplasia in Maximal Wall Thickness after one year
...ATR + ETD group vs. ATR group
Key secondary outcomes
The changing rate (%) of Total Vascular Area and Lumen Area after one year
The changing rate (%) of LDLchol value after one year
...ATR + ETD group vs. ATR group,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Atorvastatin + Etidronate (ATR+ETD) group
Janu. 2006-Apr.2008
Interventions/Control_2
Atorvastatin (ATR) group
Jan. 2006-Apr.2008
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pulse Wave Velocity > 1800
carotid artery echo: plaque score > 3
200 > LDL cholesterol > 160mg/dl
Not take an improving drug of lipid metabolism for 3 months. Not take an improving drug of osteoporosis for 3 months
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
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawahara |
Organization
Niigata Rosai Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
1-7-12, Touncho, Joetsu-shi, Niigata, Japan
TEL
025-543-3123
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawahara |
Organization
Niigata Rosai Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
1-7-12, Touncho, Joetsu-shi, Niigata, Japan
TEL
025-543-3123
Homepage URL
http://www.niigatah.rofuku.go.jp/
k-tetsuy@niirou.jp
Sponsor or person
Institute
Niigata Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata Rosai Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Public Health
Name of secondary funder(s)
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
新潟労災病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 15 | 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
Completed
Date of protocol fixation
| 2005 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 15 | Day |
Last modified on
| 2010 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004551
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
