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Recruitment status
Unique ID issued by UMIN UMIN000002059
Receipt No. R000002496
Scientific Title Research on the efficacy of eicosapentaenoic acid (EPA) on coronary plaque formation in patients undergoing percutaneous coronary intervention.
Date of disclosure of the study information 2009/06/20
Last modified on 2009/06/09

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Basic information
Public title Research on the efficacy of eicosapentaenoic acid (EPA) on coronary plaque formation in patients undergoing percutaneous coronary intervention.
Acronym ReSPECT-Study
Reduction of Soft Plaque by EPA, Clinical Tokushima Study
Scientific Title Research on the efficacy of eicosapentaenoic acid (EPA) on coronary plaque formation in patients undergoing percutaneous coronary intervention.
Scientific Title:Acronym ReSPECT-Study
Reduction of Soft Plaque by EPA, Clinical Tokushima Study
Region
Japan

Condition
Condition Patients underdoing percutaneous coronary intervention complicated with dyslipidemia.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study compares the effect on coronary plaque of strong statin therapy with that of strong statin combined with a high-purity EPA preparation in patents undergoing percutaneous coronary intervention complicated with dyslipidemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of changes in plaque formation before and after medication by integrated backscatter intravascular ultrasound (IB-IVUS).
Key secondary outcomes 1.Changes in blood inflammation and coagulation markers
hs-CRP
IL-6
TNF-alpha
IP-10
MMP-3
MMP-9
PTX3
Heparin cofactor 2
2.Blood EPA/AA ratio
3.Vascular endothelial function (flow-mediated dilatation; FMD)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention 1: Atrovastatin (Lipitor: 5 mg, 10 mg), pitavastatin (Livalo: 1 mg, 2 mg) or rosuvastatin (Crestol: 2.5 mg, 5 mg)
Interventions/Control_2 Combined application of high-purity EPA preparation (Epadel 1,800 mg) with intervention 1.
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 1) Patients in which stenosis is found to exceed 75% in 1-2 vessels, prompting implantation of a bare-metal stent (BMS) by percutaneous coronary intervention (PCI).

2) Patients with LDL cholesterol 160 mg/dl or above, patients having taken strong statin, or mild statin with LDL cholesterol 100 mg/dl or above.
Key exclusion criteria 1. Patients with a past history of hypersensitivity to high-purity EPA preparations.
2. Patients suffering a stroke within the previous 6 months.
3. Patients with a left vetricular ejection fraction of 40% or less.
4. Patients on dialysis.
5. Patients with bleeding (hemophilia, capilary fragility, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhaging etc.).
6. Patients with peptic ulcers.
7. Patients considered unsuitable for other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka SATA
Organization The University of Tokushima
Institute of Health Biosciences, Graduate School.
Division name Cardiovascular Medicine.
Zip code
Address 3-18-15, Kuramoto-cho,
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokushima Institute of Health Biosciences, Graduate School.
Division name Cardiovascular Medicine.
Zip code
Address
TEL 088-633-7852
Homepage URL
Email

Sponsor
Institute Cardiovascular Medicine. The University of Tokushima Institute of Health Biosciences, Graduate School.
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 20 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
Date of protocol fixation
2009 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 10 Day
Last modified on
2009 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002496

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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