Unique ID issued by UMIN | UMIN000008303 |
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Receipt number | R000009781 |
Scientific Title | Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque. |
Date of disclosure of the study information | 2012/06/30 |
Last modified on | 2012/06/29 16:21:30 |
Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque.
TART study
Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque.
TART study
Japan |
Hypercholesterolemia with carotid artery plaque
Medicine in general | Cardiology | Endocrinology and Metabolism |
Neurology | Neurosurgery |
Others
NO
To assess the effect of pitavastatin on the carotid plaques in patients with hypercholesterolemia.
Efficacy
Exploratory
Pragmatic
Not applicable
Qualitative and quantitative change of carotid artery plaque by carotid artery echo and MRI evaluation.
1)Change of serum lipids(TC,LDL-C,TG,HDL-C).
2)Incidence rate of event.
3)Change of hs-CRP and osteopontin.
4)Evaluation of carotid artery plaque by microbubble contrast material.
5)Evaluation of carotid artery plaque by contrast-enhanced CT.
6) Relationship of change of carotid artery plaque and serum lipids, blood marker.
7)Change of intracranial stenosis.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Pitavastatin will be administered for 6 months at a dosage of 1~4 mg/day.
20 | years-old | <= |
Not applicable |
Male and Female
1)The patient who observed the plaque in the carotid artery by MRI(Not less than 50% of the degree of stenosis).
2)The patient who is going not to perform CAS and CEA etc. but to perform
Follow up.
3)At the time of entry, pitavastatin is not taken.
4)Patients with hypercholesterolemia.
5)Patients aged 20 years or older at the time of giving consent.
6)Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial.
1)At the time of entry, pitavastatin is taken.
2)The patient who had enforced CAS in the past to the carotid artery plaque lesion which evaluates.
3)Patients who have hypersensitivity to LIVALO tablet.
4)Patients who are being treated with cyclosporine.
5)Patients who have liver dysfunction
The following patients considered that biliary obstruction or liver metabolism ability is falling(acute hepatitis, Acute aggravation of chronic hepatitis, hepatic cirrhosis, hepatoma, jaundice)
6)Pregnant women, women suspected of being pregnant, or lactating women
7)Patients who have renal dysfunction, or undergoing dialysis.
8)Patients who are ineligible in the opinion of the investigator.
50
1st name | |
Middle name | |
Last name | Yoshiaki Kumon |
Ehime University
Neurosurgery
Shitsukawa, Toon-shi, Ehime
089-964-5338
1st name | |
Middle name | |
Last name | Yoshiaki Kumon |
Ehime University
Neurosurgery
Shitsukawa, Toon-shi, Ehime
089-964-5338
ykumon@m.ehime-u.ac.jp
Ehime University
None
Self funding
NO
2012 | Year | 06 | Month | 30 | Day |
Unpublished
Open public recruiting
2012 | Year | 05 | Month | 28 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 29 | Day |
2012 | Year | 06 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009781
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