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A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)

Status: Recruiting

The purpose of this study is to learn whether the study treatment, inclisiran, taken in addition to standard cholesterol-lowering medication, can safely reduce the risk of heart attack, stroke, and other serious heart-related events in people with established cardiovascular disease.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 40 years old
• fasting LDL-C at least 70 mg/dL
• stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen including a high-intensity statin therapy (atorvastatin or rosuvastatin)
• any of the following three conditions 1) heart attack (myocardial infarction), 2) stroke, or 3) symptomatic peripheral arterial disease (PAD)
Exclusion Criteria:

• Heart attack, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease less than 4 weeks
• treatment with PCSK9 inhibitors (evolocumab or alirocumab) within past 90 days
• planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months starting the study
• cancer treated with surgery radiation therapy and/or systemic therapy during the past 3 years
• other significant medical conditions (study staff will review)
• women who are pregnant or breast feeding
Conditions:

Heart & Vascular

Keywords:

Atherosclerotic Cardiovascular Disease, Clinics and Surgery Center (CSC), Heart Attack, Myocardial Infarction, PAD

Study Contact: Natalie Erichsen - erich018@umn.edu
Principal Investigator: Daniel Duprez
Phase: PHASE3
IRB Number: SITE00001488
See this study on ClinicalTrials.gov

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