UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012069
Receipt number R000014051
Scientific Title Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid
Date of disclosure of the study information 2013/10/21
Last modified on 2022/05/11 17:26:58

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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


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



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 Hiroyuki
Middle name
Last name Daida

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Cardiology

Zip code

113-8421

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 Kumiko
Middle name
Last name Kitagawa

Organization

Research Institute for Production Development

Division name

Secretariat of RESPECT-EPA

Zip code

606-0805

Address

15, Shimogamo Morimoto-cho, Sakyo-ku, Kyoto, 606-0805

TEL

075-781-1107

Homepage URL


Email

jimu-epa@world.odn.ne.jp


Sponsor or person

Institute

Study group on treatment of coronary artery disease

Institute

Department

Personal name



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

Juntendo University

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5802-1589

Email

chiken@juntendo.ac.jp


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

2013 Year 05 Month 24 Day

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014051


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name