This study focuses on people at high risk of cardiovascular disease who have not previously experienced a myocardial infarction (heart attack) or stroke. The research examines the effectiveness of a medication called evolocumab (also known as AMG 145) compared to placebo in preventing serious heart and blood vessel problems. Evolocumab is a medication that helps lower cholesterol levels in the blood.
The study aims to determine if evolocumab can reduce the risk of death from coronary heart disease, heart attacks, and strokes in people receiving standard cholesterol-lowering therapy. The medication is given as an injection under the skin using a pre-filled pen that contains 140 mg of evolocumab.
During the study, participants will receive either evolocumab injections or placebo injections. The treatment period lasts for 72 weeks, during which participants will continue their usual cholesterol-lowering medications. The study will track various heart-related health events, including arterial revascularization (procedures to restore blood flow in blocked arteries) and death from heart-related causes.
1Initial treatment assignment
You will be randomly assigned to receive either evolocumab or a placebo (an inactive substance).
The assignment is double-blind, which means neither you nor your doctor will know which treatment you are receiving.
2Treatment administration
You will receive subcutaneous injections (under the skin) of either evolocumab or placebo.
The treatment will continue throughout the study period, which runs until June 30, 2025.
3Ongoing medical care
You will continue receiving your regular lipid-lowering therapy (medications to control cholesterol) throughout the study.
Regular monitoring of your heart health and blood tests will be conducted to track your progress.
4Health monitoring
Your health will be monitored for important heart-related events, including:
– Heart problems (coronary heart disease)
– Heart attacks (myocardial infarction)
– Brain blood vessel blockages (ischemic stroke)
– Need for blood vessel procedures (arterial revascularization)
5Study completion
The study will conclude on June 30, 2025.
Your participation will help determine if evolocumab reduces the risk of serious heart-related events in patients at high cardiovascular risk.
Who Can Join the Study?
Age requirements: men must be 50 years or older, women must be 55 years or older, and all participants must be under 80 years old
Must have specific blood fat levels:
LDL (bad cholesterol) of at least 90 mg/dL, or
non-HDL cholesterol of at least 120 mg/dL, or
apolipoprotein B of at least 80 mg/dL
Must have at least one of these heart-related conditions:
Significant heart artery disease with previous procedures or blockages
Significant blood vessel problems affecting the brain
Significant blood vessel problems in the legs
Diabetes with complications affecting small blood vessels
Must have at least one additional risk factor:
Blood vessel disease in multiple areas of the body
Diabetes or metabolic syndrome
Very high cholesterol levels
High levels of lipoprotein(a) in blood
Inherited high cholesterol
Family history of early heart disease
High levels of inflammation markers in blood
Current smoker
Over 65 years of age
Early menopause (before age 40)
Reduced kidney function
High calcium buildup in heart arteries
Who Cannot Join the Study?
Prior history of heart attack (myocardial infarction) or stroke
Currently participating in other clinical research studies
Known allergies to the study medication (evolocumab) or its components
Significant liver disease or abnormal liver function tests
Severe kidney problems (severe renal impairment)
Uncontrolled high blood pressure
History of serious bleeding disorders
Pregnant women or women planning to become pregnant during the study
Breastfeeding mothers
Active cancer or cancer treatment within the past 5 years
History of substance abuse within the past year
Mental conditions that could interfere with study participation
Unable to provide informed consent
History of not following medical treatment plans
Taking medications that could interact with the study drug
Evolocumab is a medication that helps lower cholesterol levels in the blood. It works by blocking a protein that prevents the liver from removing LDL (bad) cholesterol from the blood. This medication is used in patients who have a high risk of cardiovascular problems but haven’t had a heart attack or stroke. It is given alongside other cholesterol-lowering treatments to help reduce the risk of serious heart problems.
Placebo is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used to help determine if the actual medication is effective.
Note: Both medications in this trial are given to patients who are already receiving optimized lipid-lowering therapy as part of their standard treatment for managing cardiovascular risk.
Coronary Heart Disease (CHD) – A condition where the main blood vessels that supply the heart become narrowed or blocked by fatty deposits. This process develops gradually over time as cholesterol and other materials build up on the inner walls of arteries. The reduced blood flow can cause chest pain and eventually lead to a heart attack if a coronary artery becomes completely blocked. The disease often progresses silently for many years before showing symptoms.
Myocardial Infarction (MI) – A condition where part of the heart muscle is damaged due to insufficient blood supply. It occurs when one or more coronary arteries become blocked, preventing oxygen-rich blood from reaching certain areas of the heart. The affected heart muscle begins to die within minutes of being deprived of oxygen. The damage can vary in size and severity depending on the duration and location of the blockage.
Ischemic Stroke – A condition where blood flow to a part of the brain is blocked, typically by a blood clot. When brain tissue is deprived of oxygen and nutrients, brain cells begin to die within minutes. The effects of an ischemic stroke depend on which area of the brain is affected and how much tissue is damaged. The condition can cause sudden weakness, confusion, or difficulty speaking.
Cardiovascular Disease – A group of disorders affecting the heart and blood vessels throughout the body. The condition typically develops when arteries become hardened and narrowed due to the buildup of fatty deposits. This process can affect blood vessels throughout the body, including those supplying the heart, brain, and other vital organs. The disease often develops gradually over many years.
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