Unique ID issued by UMIN | UMIN000003756 |
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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 |
Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Prospective Open Label Trial-
Aortic Plaques Prevention Trial by Etidronate and Atorvastatin
Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Prospective Open Label Trial-
Aortic Plaques Prevention Trial by Etidronate and Atorvastatin
Japan |
Hyperlipidemia, Diabetes, Hypertension, Osteoporosis
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
Not applicable
The changing rate (%) of hyperplasia in Maximal Wall Thickness after one year
...ATR + ETD group vs. ATR group
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,
Interventional
Parallel
Non-randomized
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
Atorvastatin + Etidronate (ATR+ETD) group
Janu. 2006-Apr.2008
Atorvastatin (ATR) group
Jan. 2006-Apr.2008
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
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.
80
1st name | |
Middle name | |
Last name | Tetsuya Kawahara |
Niigata Rosai Hospital
Endocrinology and Metabolism
1-7-12, Touncho, Joetsu-shi, Niigata, Japan
025-543-3123
1st name | |
Middle name | |
Last name | Tetsuya Kawahara |
Niigata Rosai Hospital
Endocrinology and Metabolism
1-7-12, Touncho, Joetsu-shi, Niigata, Japan
025-543-3123
http://www.niigatah.rofuku.go.jp/
k-tetsuy@niirou.jp
Niigata Rosai Hospital
Niigata Rosai Hospital
Non profit foundation
Japan
National Institute of Public Health
NO
新潟労災病院(新潟県)
2010 | Year | 06 | Month | 15 | Day |
Unpublished
Completed
2005 | Year | 12 | Month | 01 | Day |
2006 | Year | 01 | Month | 01 | Day |
2008 | Year | 04 | Month | 01 | Day |
2008 | Year | 06 | Month | 01 | Day |
2008 | Year | 07 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2010 | Year | 06 | Month | 15 | Day |
2010 | Year | 11 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004551
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