UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002059 |
|---|---|
| Receipt number | 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 09:39:04 |
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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
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
Sponsor or person
Institute
Cardiovascular Medicine. The University of Tokushima Institute of Health Biosciences, Graduate School.
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002496
