UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012852
Receipt number R000015017
Scientific Title Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases
Date of disclosure of the study information 2014/01/16
Last modified on 2020/01/19 12:31:54

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Basic information

Public title

Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases

Acronym

Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases

Scientific Title

Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases

Scientific Title:Acronym

Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases

Region

Japan


Condition

Condition

Patients with atherosclerotic diseases

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Patients with atherosclerotic disease (EPA/AA under 0.4) receiving LDL-C lowering treatment by statin will be randomized to either a control group (standard treatment) or EPA group (standard treatment plus EPA), to examine the effects of EPA 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


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary endpoints are the first occurrence of any of the following cardiovascular events.
All cause death, cardiovascular death, non-fatal myocardial infarction (MI)*, non-fatal stroke, coronary artery bypass grafting (CABG), and resuscitation from cardiac arrest.
* 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.
Unstable angina requiring emergent hospitalization and coronary revascularization, and coronary revascularization based on clinical findings.
2) Event relating to death
Occurrence of each following event;
1) All-cause death
2) Cardiovascular death
3) Cardiac death
(2) 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
(3) 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
(4) 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
(5) Biomarkers


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

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with atherosclerotic diseases who took statin over one month and met all following criteria;
(1) Patients aged 20 years to 99 years at the time of informed consent
(2) Patients given written informed consent

atherosclerotic diseases 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 (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

100


Research contact person

Name of lead principal investigator

1st name Toshikazu
Middle name
Last name 7

Organization

National hospital organization
Minamiwakayama Medical Center

Division name

Department of Cardiology

Zip code

646-8558

Address

27-1, Takainai-cho, Tanabe city, Wakayama, Japan

TEL

0739267050

Email

hashidumet98999@yahoo.co.jp


Public contact

Name of contact person

1st name Toshikazu
Middle name
Last name Hashizume

Organization

National hospital organization

Division name

Department of Cardiology

Zip code

6468558

Address

27-1, Takainai-cho, Tanabe city, Wakayama, Japan

TEL

0739-26-7050

Homepage URL


Email

hashidumet98999@yahoo.co.jp


Sponsor or person

Institute

National hospital organization
Minamiwakayama Medical Center

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

National hospital organization Minamiwakayama Medical Center

Address

27-1, Takainai-cho, Tanabe city, Wakayama, Japan

Tel

0739267050

Email

hashidumet98999@yahoo.co.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

南和歌山医療センター(和歌山県)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 16 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

Preinitiation

Date of protocol fixation

2013 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 14 Day

Last modified on

2020 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015017


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name