UMIN-CTR Clinical Trial

Basic information
Public title	Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid
Acronym	RESPECT-EPA
Scientific Title	Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid
Scientific Title:Acronym	RESPECT-EPA
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients with chronic coronary artery disease receiving LDL-C lowering treatment by statin will be randomized to either a control group (standard treatment) or EPA group (standard treatment plus eicosapentaenoic acid), to examine the effects of eicosapentaenoic acid on the incidence of cardiovascular events. Relationship between EPA/AA ratio and incidence of event will be also examined.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Primary endpoints are the first occurrence of any of the following cardiovascular events. Cardiovascular death, non-fatal myocardial infarction (MI)*, non-fatal cerebral infarction, unstable angina requiring emergent hospitalization and coronary revascularization, and coronary revascularization based on clinical findings. * indicates not including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) related MI.
Key secondary outcomes	(1) Composite endpoint. 1) Composite event of coronary artery disease Endpoints are the first occurrence of any of the following events. Cardiac sudden death, fatal/non-fatal MI*, unstable angina requiring emergent hospitalization and coronary revascularization, and coronary revascularization based on clinical findings. 2) Composite event of cerebrovascular disorders Endpoints are the first occurrence of any of the following events. 2-1) Fatal/non-fatal stroke, hospitalization due to transient ischemic attack. 2-2) Fatal/non-fatal stroke (2) Event relating to death Occurrence of each following event; 1) All-cause death 2) Cardiovascular death 3) Cardiac death (3) Event relating to cardiac disease Occurrence of each following event; 1) Fatal/non-fatal MI* 2) PCI related MI 3) CABG related MI 4) Stent thrombosis associated with MI 5) Cardiac sudden death 6) Unstable angina requiring emergent hospitalization and coronary revascularization 7) Resuscitation from cardiac arrest 8) Hospitalization due to heart failure 9) New-onset of atrial fibrillation 10) Coronary revascularization (PCI or CABG) 10-1) All coronary revascularization (a) TLR (b) TVR (c) TVR-Remote (d) Non-TVR 10-2) Coronary revascularization based on clinical findings (a) TLR (b) TVR (c) TVR-Remote (d) Non-TVR (4) Events relating to cerebrovascular disorders Occurrence of each following event; 1) Fatal/non-fatal cerebral hemorrhage 2) Fatal/non-fatal stroke 3) TIA requiring hospitalization (5) Other events Occurrence of each following event; 1) Revascularization to peripheral artery disease (PAD) 2) Carotid artery stenting (CAS) or carotid endarterectomy (CEA) 3) Deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE) 4) New occurrence of malignant tumor 5) Progression to dialysis 6) Hemorrhagic event (6) Biomarkers

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous administration of statin + EPA 1800mg/day
Interventions/Control_2	Continuous administration of statin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with CAD who took statin over one month and met all following criteria; (1) Patients aged 20 years to 79 years at the time of informed consent (2) Patients given written informed consent CAD is defined as having at least one of the following criteria (1) to (3); (1) History of acute coronary syndrome (acute myocardial infarction or unstable angina) (2) History of coronary revascularization (PCI or CABG) (3) Clinically diagnosed ischemic heart disease and severe coronary artery stenosis (75% or higher according to AHA classification) demonstrated in coronary angiography
Key exclusion criteria	Patients who meet one of the following criteria; (1) Patients on dialysis (2) Patients with serious hepatic disease (3) Patients with active malignant tumor (4) Patients for whom coronary angiography or coronary revascularization is scheduled but not yet conducted (5) Patients with severe heart failure (LVEF<30% or NYHA class 3 or 4 according to NYHA classification) (6) Patients who experienced acute coronary syndrome (acute myocardial infarction or unstable angina) within three month at the time of informed consent (7) Patients who received coronary revascularization (PCI or CABG) within three month at the time of informed consent (8) Patients with inadequately controlled diabetes mellitus[HbA1c (JDS): 8.0% or more, HbA1c (NGSP): 8.4% or more] (9) Patients with secondary dyslipidemia associated with (a) nephrotic syndrome, (b) hypothyroidism, (c) Cushing syndrome and (d) other diseases, patients with drug-induced dyslipidemia such as that caused by steroid hormone, or patients receiving EPA (including OTC drugs) or EPA/DHA, or having received such drug within previous 1 month at the time of informed consent (10) Patients having active bleeding or bleeding tendency (11) Patients with a history of adverse reaction to EPA (12) Patients participating in other clinical trial (13) Pregnant women, possibly pregnant women, or women during lactation (14) Other patients who, in the opinion of the participating physician, are not eligible
Target sample size	3900

Research contact person
Name of lead principal investigator	1st name Middle name Last name Daida
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiology
Zip code
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Email	daida@juntendo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kitagawa
Organization	Research Institute for Production Development
Division name	Secretariat of RESPECT-EPA
Zip code
Address	15, Shimogamo Morimoto-cho, Sakyo-ku, Kyoto, 606-0805
TEL	075-781-1107
Homepage URL
Email	jimu-epa@world.odn.ne.jp

Sponsor
Institute	Study group on treatment of coronary artery disease
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Heart Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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	2013 Year 10 Month 21 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	No longer recruiting
Date of protocol fixation	2013 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 09 Month 15 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 18 Day
Last modified on	2022 Year 05 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014051

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