UMIN-CTR Clinical Trial

Public title

Effects of eicosapentaenoic acid on cardiovascular events in Japanese high risk patients

Acronym

Effects of Response with Eicosapentaenoic Acid on Cardiovascular events in japanese High risk patients (E-REACH study)

Scientific Title

Effects of eicosapentaenoic acid on cardiovascular events in Japanese high risk patients

Scientific Title:Acronym

Effects of Response with Eicosapentaenoic Acid on Cardiovascular events in japanese High risk patients (E-REACH study)

Region

Japan

Condition

Cardiovascular disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We investigate the effects of eicosapentaenoic acid on the secondary prevention of major coronary events in high risk patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Combined end point of cardiovascular death, nonfatal MI , vascular interventions , hospitalizations for ischemic events, nonfatal stroke

Key secondary outcomes

1.All causes death 2.Cardiovascular death 3. Fatal or nonfatal MI 4 Hospitalizations for ischemic events 5. Coronary interventions 6. Fatal or nonfatal stroke 7. Hospitalizations for congestive heart failure 8. Vascular interventions 9. the change of the eicosapentanoic/ arachidonic acid ratio at baseline and follow-up 10. Adverse events : Life-threatening bleeding and Major bleeding and Minor bleeding

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Eicosapentaenoic acid

Interventions/Control_2

Standard therapy( antplatelet agent and stains )

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

The high risk patients of atherothrombosis 1. Myocardial infarction events within 1 years 2. Polyvascular disease which defined as having atherothrombosis in 2 or 3 aretrial beds ( coronary, peripheral, cerebrovascular) 3. Patients with coronary , cerebrovascular , peripheral artery disease had diabets

Key exclusion criteria

1) Acute myocardial infarction occurring within last 6 months
2) Unstable angina pectoris
3) Patinets intending to undergo interventions
4) A history or complication of serious heart disease (sever arrhythmia, heart failure, cardio myopathy, vascular diease, congenital heart diease,etc)
5) Receiving cardiovascular reconstructions within last 6 months
6) Complications of serious hepatic disease or renal disease
7) Malignant tumor
8) Uncontrollable diabetes
9) Familial hyperlipidemia
10) Hemorrage
11) Hypersensitivity to the study drug formulation
12) Patients intending undergo surgery
13) Patients judged to be inappropriate by the physician in charge

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Kazuki Fukui

Organization

Kanagawa Cardiovascular and Respiratory Center

Division name

Department of Cardiology

Zip code

Address

6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama, Kanagawa,236-0051 JAPAN

TEL

045-701-9581

Email

fukui@kanagawa-junko.jp

Name of contact person

1st name
Middle name
Last name	Yuuko Okamoto

Organization

Kanagawa Cardiovascular and Respiratory Center

Division name

The Secretary of medical stuff

Zip code

Address

6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama, Kanagawa,236-0051 JAPAN

TEL

045-701-9581

Homepage URL

Email

okamoto@kanagaw-junko.jp

Institute

Kanagawa Cardiovascular and Respiratory Center

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

神奈川県立循環器呼吸器病センター（神奈川県）横浜栄共済病院（神奈川県）　
横浜南共済病院（神奈川県）横浜市脳血管センター　（神奈川県）
国際親善総合病院（神奈川県）　
横浜船員保険病院（神奈川県）　　
（独）国立病院機構相模原病院（神奈川県）
茅ヶ崎市立病院（神奈川県）
横須賀市立市民病院（神奈川県）

Date of disclosure of the study information

2012

Year

02

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2012

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

02

Month

11

Day

Last modified on

2013

Year

09

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008573