UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Rosuvastatin and eicosapentaenoic acid on neoatherosclerosis: The LINK-IT trial
Acronym	Effect of Rosuvastatin and eicosapentaenoic acid on neoatherosclerosis: The LINK-IT trial
Scientific Title	Effect of Rosuvastatin and eicosapentaenoic acid on neoatherosclerosis: The LINK-IT trial
Scientific Title:Acronym	Effect of Rosuvastatin and eicosapentaenoic acid on neoatherosclerosis: The LINK-IT trial
Region	Japan

Condition
Condition	coronary artery disease patient with in-stent neoatherosclerosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aim to evaluate whether intensive lipid lowering therapy may improve the clinical outcomes in coronary artery disease patients with in-stent neoatherosclerosis, in comparison with standard therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in lipid index analyzed by optical coherence tomography
Key secondary outcomes	Ischemic driven TLR, MACE(death, myocardial infarction, TLR), and stent thrombosis, other OCT parameters

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intensive lipid lowering therapy start with EPA and Rosuvastatin 10 mg/day and up to 20 mg/day
Interventions/Control_2	Standard lipid lowering therapy start with only Rosuvastatin 2.5 mg/day and up to 20 mg/day
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients meeting all of the following conditions will be included: AN detected by OCT >1 year after stent implantation (Include any type of stent [BMS, 1st generation DES, and 2nd generation DES]) between 20 and 85 years old written consent for participation in the study
Key exclusion criteria	Patients meeting one of the following conditions will be excluded: 1) severe liver dysfunction 2) renal dysfunction (<Cre 2.0mg/dL) 3) severe heart failure (NYHA/New York Heart Association stage III or severer) 4) malignancies or other diseases with poor prognosis 5) pregnant, lactating, and possibly pregnant women and those planning to become pregnant 6) past medical history of hypersensitivity to investigational drugs 7) judged as ineligible by clinical investigators
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiromasa Middle name Last name Otake
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5111
Email	hotake@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Hiromasa Middle name Last name Otake
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5111
Homepage URL
Email	hotake@med.kobe-u.ac.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
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	IRB of Kobe University Hospital
Address	7-5-2 Kusunoki-cho Chuo-ku, Kobe City
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.jp

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	2013 Year 12 Month 14 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	Completed
Date of protocol fixation	2013 Year 11 Month 10 Day
Date of IRB	2014 Year 01 Month 15 Day
Anticipated trial start date	2014 Year 01 Month 29 Day
Last follow-up date	2017 Year 06 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 14 Day
Last modified on	2020 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014711