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
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
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
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
