UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007266
Receipt No. R000008573
Scientific Title Effects of eicosapentaenoic acid on cardiovascular events in Japanese high risk patients
Date of disclosure of the study information 2012/02/11
Last modified on 2013/09/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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


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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kanagawa Cardiovascular and Respiratory Center
Institute
Department

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
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 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)


Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 11 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 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
Other related information

Management information
Registered date
2012 Year 02 Month 11 Day
Last modified on
2013 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.