UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033335
Receipt number R000037969
Scientific Title Lesional evaluation of high-risk patients with neoatherosclerosis treated with rosuvastatin and eicosapentaenoic acid using OCT and NIRS IVUS
Date of disclosure of the study information 2018/09/01
Last modified on 2018/07/08 21:12:21

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Basic information

Public title

Lesional evaluation of high-risk patients with neoatherosclerosis treated with rosuvastatin and eicosapentaenoic acid using OCT and NIRS IVUS

Acronym

LINK IT two

Scientific Title

Lesional evaluation of high-risk patients with neoatherosclerosis treated with rosuvastatin and eicosapentaenoic acid using OCT and NIRS IVUS

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiromasa Otake

Organization

Kobe University Hospital

Division name

Cardiology

Zip code


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

1st name
Middle name
Last name Shinsuke Nakano

Organization

Kobe University Hospital

Division name

Cardiology

Zip code


Address

7-5-2 Kusunokimachi Tyuoku Kobe city Hyogo

TEL

078-382-5846

Homepage URL


Email

dqswx303@yahoo.co.jp


Sponsor or person

Institute

Kobe University

Institute

Department

Personal name



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)



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

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


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

Preinitiation

Date of protocol fixation

2018 Year 07 Month 06 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037969


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name