UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia
Acronym	The carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia
Scientific Title	Examination of the carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia
Scientific Title:Acronym	The carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia
Region	Japan

Condition
Condition	Patients with dyslipidemia
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of EPA preparation or EPA+DHA preparation on carotid plaque in patients with hyperlipidemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Carotid IMT-C10
Key secondary outcomes	Carotid maxIMT, LDL-C, HDL-C, TG, nonHDL-C, EPA, DHA, AA, DHLA, LP(a), RLP-C SAA-LDL, AT-LDL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	EPA: 1.8g/day for 24 weeks
Interventions/Control_2	EPA+DHA: 2g/day for 24 weeks
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patient with dyslipidemia have already continued the treatment of statin more than three months, and curative effect is inadequate. (2) Patient who does not take EPA preparation, EPA+DHA preparation or a supplement containing DHA and EPA. (3) Patient at the agreement acquisition 20 years or older (4) The patient that a written agreement was provided by the free will of the person after enough understanding about The participation in this study
Key exclusion criteria	(1) The patient who having unstable angina before registration or has the myocardial infarction past of the onset for less than three months at registration (2) The patient who takes EPA preparation and EPA+DHA preparation (3) Hospitalized patient (4) The patient who has an allergy for a blue-skinned fish (5) During the pregnancy or the woman who is nursing it (6) It is the patients with in treatment or terminal cancer for a malignant tumor (7) When I judge a study responsibility doctor, a study allotment doctor not to be appropriate about the participation of this study
Target sample size	66

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Morimoto
Organization	University of Shizuoka
Division name	Division of Molecular Medicine, Graduate School of Pharmaceutical Sciences
Zip code	4228526
Address	52-1, Yata, Suruga-ku, Shizuoka, Shizuoka
TEL	0542645765
Email	morimoto@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Morimoto
Organization	University of Shizuoka
Division name	Division of Molecular Medicine, Graduate School of Pharmaceutical Sciences
Zip code	4228526
Address	52-1, Yata, Suruga-ku, Shizuoka, Shizuoka
TEL	0542645765
Homepage URL
Email	morimoto@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	Self funding
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	Shizuoka General Hospital
Address	4-27-1,Kitaando, Aoi-ku, Shizuoka, Shizuoka
Tel	momoko-maejima@shizuoka-pho.jp
Email	054-247-6111

Secondary IDs
Secondary IDs	YES
Study ID_1	SGHIRB#2019032
Org. issuing International ID_1	Shizuoka General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	静岡県立総合病院

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 26 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	2020 Year 01 Month 09 Day
Date of IRB	2020 Year 01 Month 30 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 26 Day
Last modified on	2020 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046257