UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007266 |
|---|---|
| Receipt number | 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 21:01:19 |
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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
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
okamoto@kanagaw-junko.jp
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008573
