UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Takashi Mizobe
Organization	Hyogo Brain and Heart Center at Himeji
Division name	Department of Neurosurgery
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	Yoshikazu Fukuda
Organization	Hyogo Brain and Heart Center at Himeji
Division name	Department of General Affairs
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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