UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011934 |
|---|---|
| Receipt number | R000013936 |
| Scientific Title | The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2014/04/01 15:57:18 |
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Basic information
Public title
The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT
Acronym
The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT
Scientific Title
The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT
Scientific Title:Acronym
The impact of additive EPA or ezetimibe to statin therapy on the stabilization of vulnerable plaque; Assessment by OCT
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to assess the impact of EPA or ezetimibe therapy on the stabilization of vulnerable plaques, using OCT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fibrous-cap thickness and lipid burden in vulnerable plaque assessed by OCT
Key secondary outcomes
The incidence of death, revascularization, myocardial infarction for 2 years
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients received daily 1800mg EPA and ordinary statin therapy for 2 years.
Interventions/Control_2
The patients received daily 10mg ezetimibe and ordinary statin therapy for 2 years.
Interventions/Control_3
The patients received ordinary statin therapy for 2 years.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent percutaneous coronary intervention (PCI) for ischemic heart diseases and having LDL levels > 100 mg/dL without lipid-lowering therapy. Of them, the patients who had vulnerable plaque were enrolled in this study.
Key exclusion criteria
Patients were excluded from the study if they (1) were already using statins or other lipid-lowering therapies, (2) had known hypersensitivity to statins or contrast, (3) had end-stage renal failure (serum creatinine [Cre] ≥ 2.0 mg/dL), (4) demonstrated hemodynamic and respiratory instability (e.g., cardiogenic shock, severe congestive heart failure), or (5) had no consent to participate.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular and Respiratory Medicine, Department of Internal Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan
TEL
078-382-5846
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Nishio |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular and Respiratory Medicine, Department of Internal Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan
TEL
078-382-5846
Homepage URL
ryo_ni_19_81_7@hotmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24637411
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
Main results already published
Date of protocol fixation
| 2009 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 01 | Day |
Last modified on
| 2014 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013936
