UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028006 |
|---|---|
| Receipt number | R000031888 |
| Scientific Title | We conduct intense LDL-C lowering therapy for patients with asymptomatic cervical internal carotid stenosis and evaluate signal change of carotid plaque on MRI-VISTA |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/11/09 09:08:14 |
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Basic information
Public title
We conduct intense LDL-C lowering therapy for patients with asymptomatic cervical internal carotid stenosis and evaluate signal change of carotid plaque on MRI-VISTA
Acronym
Study of intense lipid-lowering effect on carotid MRI signal change
Scientific Title
We conduct intense LDL-C lowering therapy for patients with asymptomatic cervical internal carotid stenosis and evaluate signal change of carotid plaque on MRI-VISTA
Scientific Title:Acronym
Study of intense lipid-lowering effect on carotid MRI signal change
Region
| Japan |
Condition
Condition
cervical internal carotid artery stenosis
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conduct intense LDL-C lowering therapy on the patients with asymptomatic carotid artery stenosis and evaluate signal change of carotid plaque on MRI-VISTA from baseline.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Signal change rate from baseline of carotid plaque on MRI-VISTA at 1 month, 2 months, 3 months, 6 months after the start of intense LDL-C lowering therapy
Key secondary outcomes
Parameter change of carotid plaque by carotid ultrasound
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
anti-PCSK9 antibody, subcutaneous, once per two weeks, for 6months
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients must meet all of the following inclusion criteria
1. Asymptomatic patients with cervical internal carotid artery stenosis of 40 to 79% stenosis
2. Patients who do not achieve the LDL-C target value on the guidelines, despite taking statin with the maximum tolerated dose approved in Japan for more than 3 months
Key exclusion criteria
Patients who meet any of the following exclusion criteria
1. Patients with symptomatic cervical internal carotid artery stenosis
2. Patients with serious renal impairment
3. Patients with hepatic dysfunction
4. MRI incompatible patients
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Mizobe |
Organization
Hyogo Brain and Heart Center at Himeji
Division name
Department of Neurosurgery
Zip code
Address
520, Saishoko, Himeji-city, Hyogo, 670-0981 Japan
TEL
+81-79-293-3131
t_mizobe@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Fukuda |
Organization
Hyogo Brain and Heart Center at Himeji
Division name
Department of General Affairs
Zip code
Address
520, Saishoko, Himeji-city, Hyogo, 670-0981 Japan
TEL
+81-79-293-3131
Homepage URL
yoshikazu_fukuda@pref.hyogo.lg.jp
Sponsor or person
Institute
Hyogo Brain and Heart Center at Himeji
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031888
