UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Lesional evaluation of high-risk patients with neoatherosclerosis treated with rosuvastatin and eicosapentaenoic acid using OCT and NIRS IVUS
Title of the study (Brief title)	LINK IT two
Region	Japan

Condition
Condition	ischemic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effect of 10 mg/day of rosuvastatin plus EPA versus 5 mg/day of rosuvastatin plus EPA 5 mg/day of rosuvastatin on the extent of neoatherosclerosis using OCT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	lipid index
Key secondary outcomes	1 Major adverse cardiac event 2 follow up OCT data Minimum lumen area, average neointimal thickness, lipid arc, lipid length, TCFA, macrophage grade 3 NIRS IVUS LCBI 4mm, plaque volume

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	36weeks 10 mg/day of rosuvastatin 1800 mg/day of eicosapentaenoic acid
Interventions/Control_2	36weeks 5 mg/day of rosuvastatin 1800 mg/day of eicosapentaenoic acid
Interventions/Control_3	36weeks 5 mg/day of rosuvastatin
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 over 20 years 2 Patients implanted EES neoatherosccrelosis with NA by OCT 3 LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin
Key exclusion criteria	1 Patients taking omega 3 fatty acid before randomization 2 Patients allergic to rosuvastatin or eicosapentaenoic acid 3 Patients with a history of hemorrhagic stroke 4 Patients taking anti cancer agent 5 Patients undergoing LDL apheresis 6 Patients with severe liver disease or severe kidney disease 7 Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of rosuvastatin 8 Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of eicosapentaenoic acid 9 Patients perfomed PCI with restenosis of target lesion 10 Pregnant women or patients with possibilty of Pregnancy or nursing woman
Target sample size	75

Research contact person
Name of lead principal investigator	Hiromasa Otake
Organization	Kobe University Hospital
Division name	Cardiology
Address	7-5-2 Kusunokimachi Tyuoku Kobe city Hyogo
TEL	078-382-5846
Email	hotake@med.kobe-u.ac.jp

Public contact
Name of contact person	Shinsuke Nakano
Organization	Kobe University Hospital
Division name	Cardiology
Address	7-5-2 Kusunokimachi Tyuoku Kobe city Hyogo
TEL	078-382-5846
Homepage URL
Email	dqswx303@yahoo.co.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Cardiology of Kobe University
Organization
Division
Category of Funding Organization	Other
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	神戸大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 06 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 07 Month 09 Day
Last modified on	2018 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037969