UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012576 |
|---|---|
| Receipt number | R000014711 |
| Scientific Title | Effect of Rosuvastatin and eicosapentaenoic acid on neoatherosclerosis: The LINK-IT trial |
| Date of disclosure of the study information | 2013/12/14 |
| Last modified on | 2020/01/09 09:15:59 |
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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
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
hotake@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014711
