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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028006
Receipt No. 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

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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
Email 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
Email yoshikazu_fukuda@pref.hyogo.lg.jp

Sponsor
Institute Hyogo Brain and Heart Center at Himeji
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031888

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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