Unique ID issued by UMIN | UMIN000002635 |
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Receipt number | 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 09:03:19 |
Synergy Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Open Label Randomized Trial-
The Joetsu Aortic Plaques Prevention Trial
Synergy Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Open Label Randomized Trial-
The Joetsu Aortic Plaques Prevention Trial
Japan |
Hyperlipidemia, Diabetes, Hypertension
Medicine in general | Cardiology | Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase IV
The changing rate (%) of hyperplasia in Maximal Wall Thickness after one year
...ATR + ETD group vs. of ATR group
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
YES
No need to know
3
Treatment
Medicine |
Atorvastatin + Etidronate (ATR+ETD) group
November 2009-March 2011
Atorvastatin (ATR) group
November 2009-March 2011
Etidronate (ETD) group
November 2009-March 2011
30 | years-old | <= |
80 | years-old | >= |
Male and Female
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
Bone Mineral Density > -1SD
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.
100
1st name | |
Middle name | |
Last name | Tetsuya Kawahara |
Niigata-Rousai Hospital
Internal Medicine
1-7-12, Touncho, Joetsu-shi, Niigata, Japan
025-543-3123
1st name | |
Middle name | |
Last name | Tetsuya Kawahara |
Niigata-Rousai Hospital
Internal Medicine
1-7-12, Touncho, Joetsu-shi, Niigata, Japan
025-543-3123
http://www.niigatah.rofuku.go.jp/
k-tetsuy@niirou.jp
Niigata-Rousai Hospital
Niigata-Rousai Hospital
Non profit foundation
National Institute of Public Health
NO
新潟労災病院(新潟県)
2009 | Year | 10 | Month | 17 | Day |
Unpublished
No longer recruiting
2009 | Year | 10 | Month | 01 | Day |
2009 | Year | 11 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2009 | Year | 10 | Month | 17 | Day |
2011 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003212
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