UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002815 |
|---|---|
| Receipt number | R000003206 |
| Scientific Title | Combination therapy of Eicosapentaenoic acid and pitavastatin for Regression of coronary plaque evaluated by integrated backscatter intravascular ultrasonography; CHERRY study |
| Date of disclosure of the study information | 2009/11/30 |
| Last modified on | 2017/12/17 10:45:57 |
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Basic information
Public title
Combination therapy of Eicosapentaenoic acid and pitavastatin for Regression of coronary plaque evaluated by integrated backscatter intravascular ultrasonography; CHERRY study
Acronym
EPA and pitavastatin therapy for coronary plaque
Scientific Title
Combination therapy of Eicosapentaenoic acid and pitavastatin for Regression of coronary plaque evaluated by integrated backscatter intravascular ultrasonography; CHERRY study
Scientific Title:Acronym
EPA and pitavastatin therapy for coronary plaque
Region
| Japan |
Condition
Condition
stable angina or acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of combination therapy with Eicosapentaenoic acid and pitavastatin on coronary plaque volume and tissue characteristics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of tissue characteristics in coronary plaque evaluated by integrated backscatter intravascular ultrasonography
Key secondary outcomes
1) Changes in volume and minimum intravascular lumen diameter of target coronary plaque. 2) Changes in TC, LDL-C, TG, HDL-C, MDA-LDL, RLP-C, Lp(a) and apoprotein (Apo A-I, Apo B, Apo E). 3) Changes in EPA/arachidonic acid. 4) Changes in hs-CRP. 5) Changes in volume and minimum intravascular lumen diameter of coronary plaque undergone PCI. 6) Changes in % stenosis. 7) Incidence of major adverse cardiovascular events (MACE; defined as cardiac death, nonfatal myocardial infarction, PCI or coronary artery bypass grafting)
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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pitavastatin
Interventions/Control_2
pitavastatin and EPA
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with stable angina or acute coronary syndrome received PCI whose LDL-cholesterol level is above 140 mg/dL or eligible for the study determined by physicians.
Key exclusion criteria
1) Patients whose target lesion site is coronary bypass graft. 2) Patients who have undergone previous PCI on the lesion site where the evaluation of integrated backscatter intravascular ultrasonography is planned. 3) Patients who might undergo PCI on the lesion site where the evaluation of integrated backscatter intravascular ultrasonography is planned. 4) Patients with familial hypercholesterolemia. 5) Patients with a past history of allergy to EPA and/or pitavastatin. 6) Patients with hepatic dysfunction (ALT 100 IU/L or more) and/or biliary obstruction. 7) Patients with renal dysfunction (serum creatinine 2.0 mg/dL or more) or undergoing dialysis. 8) Patients ineligible for the study determined by physicians.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Kubota |
Organization
Yamagata University School of Medicine
Division name
Department of Cardiology, Pulmonology, and Nephrology
Zip code
Address
2-2-2 Iida-Nishi, Yamagata 990-9585
TEL
023-628-5302
ikubota@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Watanabe |
Organization
Yamagata University School of Medicine
Division name
Department of Cardiology, Pulmonology, and Nephrology
Zip code
Address
2-2-2 Iida-Nishi, Yamagata 990-9585
TEL
023-628-5302
Homepage URL
tewatana@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University School of Medicine, Department of Cardiology, Pulmonology, and Nephrology
Institute
Department
Personal name
Funding Source
Organization
Yamagata University School of Medicine, Department of Cardiology, Pulmonology, and Nephrology
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
山形大学医学部附属病院（山形県）、山形県立中央病院（山形県）、日本海総合病院（山形県）、山形県立新庄病院（山形県）、公立置賜総合病院（山形県）、山形市立病院済生館（山形県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0914508717302009?via%3Dihub
Number of participants that the trial has enrolled
Results
We enrolled 193 CHD patients who underwent percutaneous coronary intervention (PCI) in six hospitals. Patients were randomly allocated to the PTV group (PTV 4 mg/day, n = 96) or PTV/EPA group (PTV 4 mg/day and EPA 1800 mg/day, n = 97), and prospectively followed for 6-8 months. Coronary plaque volume and composition in nonstenting lesions were analyzed by integrated backscatter intravascular ultrasound (IB-IVUS).Results: The PTV/EPA group showed a greater reduction in total atheroma volume compared to PTV group. IB-IVUS analyses revealed that lipid volume was significantly decreased during follow-up period in only PTV/EPA group. The efficacy of additional EPA therapy on lipid volume reduction was significantly higher in stable angina pectoris (SAP) patients compared to acute coronary syndrome patients. EPA/AA ratio was significantly improved in PTV/EPA group compared to PTV group. There was no significant difference in the incidence of major adverse cardiovascular events and side effects.
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
| 2009 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 16 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 16 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 30 | Day |
Last modified on
| 2017 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003206
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
