Unique ID issued by UMIN | UMIN000006060 |
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Receipt number | R000007172 |
Scientific Title | A multicenter randomized comparative study to know the effects of atorvastatin on the plaque stability before carotid artery stenting |
Date of disclosure of the study information | 2011/09/01 |
Last modified on | 2014/09/03 20:33:11 |
A multicenter randomized comparative study to know the effects of atorvastatin on the plaque stability before carotid artery stenting
Atorvastatin Before Carotid Artery Stenting(AB-CAS) Trial
A multicenter randomized comparative study to know the effects of atorvastatin on the plaque stability before carotid artery stenting
Atorvastatin Before Carotid Artery Stenting(AB-CAS) Trial
Japan |
carotid artery stenosis
Vascular surgery | Neurosurgery |
Others
NO
The aim of this study is to elucidate the effect of preoperative administration of atorvastatin on the carotid artery plaque stability and postoperative cerebral embolism after carotid artery stenting in patient with high-grade stenosis
Efficacy
Exploratory
Pragmatic
Not applicable
Number of newly appeared high intensity spots on the diffusion weighted MRI(DW-MRI) within 3 days after CAS
1)Plaque quality change on MRI plaque imaging during operation waiting period
2)Changes of maximum intima-media complex thickness(IMT) and peak systolic velocity(PSV) on carotid duplex scan during operation waiting period
3)Volume of new high intensity spots on the DW-MRI performed 1-3 days after CAS
4)Serum lipid change(Total cholesterol,HDL-C,triglyceride and LDL-C)
5)Incidence of major cardiovascular events(non-fatal myocardial infarction,stroke,cardiovascular death and revascularization) until 12 weeks after CAS
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Atorvastatin 20mg/day for 4 weeks before carotid artery stenting and 12 weeks after carotid artery stenting
Medical treatment without atorvastatin for 4 weeks before carotid artery stenting and 12 weeks after carotid artery stenting
20 | years-old | <= |
80 | years-old | > |
Male and Female
Inclusion criteria
1)Patient whose age is between 20 and 80 years
2)LDL-cholesterol < 160mg/dL
3)The patients with symptomatic stenosis (>=50%) or asymptomatic stenosis (>=80%) who is eligible for carotid artery stenting
4)Patient who signed an informed consent form
Exclusion criteria
1)Patients who were administrated statins within a month
2)Patients who have liver dysfunction (ALT and/or AST > 100IU/L)
3)Patients who have kidney dysfunction (serum creatinine > 1.5 mg/dL)
4)Patients who have history of allergy to statins
5)Women who is wishing a baby, pregnant or nursing
6)Patients who are inappropriate to participate in this study
200
1st name | |
Middle name | |
Last name | Shinichi Yoshimura |
Hyogo College of Medicine
Department of Neurosurgery
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
+81-798-45-6455
s-yoshi@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Shinichi Yoshimura |
Hyogo College of Medicine
Department of Neurosurgery
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
+81-798-45-6455
s-yoshi@hyo-med.ac.jp
Hyogo College of Medicine
none
Self funding
Ichinomiya Nishi Hospital
Ube Kosan Central Hospital
Hyogo Medical University
Hiroshima University
NO
2011 | Year | 09 | Month | 01 | Day |
Unpublished
Preinitiation
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2015 | Year | 10 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2011 | Year | 07 | Month | 28 | Day |
2014 | Year | 09 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007172
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