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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002815
Receipt No. 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

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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
Email 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
Email tewatana@med.id.yamagata-u.ac.jp

Sponsor
Institute Yamagata University School of Medicine, Department of Cardiology, Pulmonology, and Nephrology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003206

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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