UMIN-CTR Clinical Trial

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
Email

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/
Email	k-tetsuy@niirou.jp

Sponsor
Institute	Niigata Rosai Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004551

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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