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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007266
Enrollment
200
Registered
2012-02-11
Start date
2012-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

Eicosapentaenoic acid Standard therapy( antplatelet agent and stains )

Sponsors

Kanagawa Cardiovascular and Respiratory Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYuka Onoda

Kanagawa Cardiovascular and Respiratory Center clinical laboratory

onoda.3810g@kanagawa-pho.jp045-701-9581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026