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

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 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


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

Value
https://center6.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