A study to determine the effectiveness and safety of AMR101 in reducing the risk of cardiovascular events (e.g. stroke, heart attack, unstable angina) in patients with high triglyceride levels and who are on statin treatments.

A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients with Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events with EPA â?? Intervention Trial) - REDUCE-IT

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002653

Enrollment

7990

Registered

2012-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Cardiovascular Diseases

Interventions

Intervention1: AMR101: Oral, 4g daily (2 capsules of 1g given twice daily plus statin therapy) Duration of Therapy: 18 Months Control Intervention1: Placebo capsule: Oral, 4 capsules daily (2 capsules

Eligibility

Inclusion criteria

Inclusion criteria: • Men and non-pregnant or sterile women ages 45 and older • Hypertriglyceridemia • On statin therapy for at least four weeks • Either having established Cardiovascular Disease or at high risk for Cardiovascular Disease

Exclusion criteria

Exclusion criteria: • Severe heart failure • Any life-threatening disease other than Cardiovascular Disease • Active severe liver disease • Hemoglobin A1c 10.0% • Poorly controlled hypertension • Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure • Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III) • Known hypersensitivity to fish oil products • History of acute or chronic pancreatitis • Patients are excluded if using the following medications: o niacin 200 mg/day or fibrates; o any omega-3 fatty acid medications; o dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil); o bile acid sequestrants

Design outcomes

Primary

Measure	Time frame
Composite endpoint of CV death, MI, stroke, coronary revascularization, and hospitalization for unstable anginaTimepoint: 4-6 years	—

Secondary

Measure	Time frame
Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc.Timepoint: 4-6 years	—

Countries

Australia, Canada, India, Netherlands, New Zealand, Poland, Romania, Russian Federation, South Africa, Ukraine, United States of America

Contacts

Public ContactSanjay Kabra

PharmaNet Clinical Services Pvt. Ltd.

skabra@pharmanet-i3.com912240957478

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026