This clinical trial is focused on studying the effects of a medication called Inclisiran on preventing major heart-related events in people who are at high risk but have not yet experienced such events. The study is specifically looking at the prevention of a condition known as atherosclerotic cardiovascular disease, which involves the buildup of fatty deposits in the arteries that can lead to heart attacks or strokes. Participants in the study will receive either Inclisiran or a placebo, which is a substance with no active medication, to compare the effectiveness of the treatment.
The purpose of the study is to determine if Inclisiran can reduce the risk of serious heart problems, such as heart attacks, strokes, or the need for urgent procedures to restore blood flow to the heart. The study will be conducted over a period of time, during which participants will receive regular injections of the medication or placebo and will be monitored for any heart-related events. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.
Participants will be closely observed throughout the study to track the time it takes for any major heart events to occur. The study will also look at other outcomes, such as the time to cardiovascular death and overall mortality. The goal is to gather information on the safety and effectiveness of Inclisiran in preventing heart-related issues in people who are at high risk but have not yet had a major cardiovascular event.
1joining the study
Upon joining the study, you will be required to provide written informed consent. This is a document that confirms your understanding of the study and your agreement to participate.
2initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, which should be between 40 and 79 years, and assessing your risk for cardiovascular events.
Your medical history will be reviewed, and tests may be conducted to check for conditions like coronary artery disease or to measure your coronary artery calcium score.
3medication administration
If eligible, you will be randomly assigned to receive either the study medication, inclisiran, or a placebo. A placebo is a substance with no active medication, used for comparison.
The medication is administered via subcutaneous injection, which means it is injected under the skin. The dosage and frequency will be determined by the study protocol.
4ongoing monitoring
Throughout the study, regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits may include physical exams, blood tests, and other assessments.
You will be asked to report any side effects or changes in your health during these visits.
5completion of the study
The study is expected to continue until April 2029. Upon completion, a final assessment will be conducted to evaluate your health and the outcomes of the study.
You will be informed about the results of the study and any relevant findings related to your health.
Who Can Join the Study?
Provide written informed consent before any study-related assessments are done. This means you agree to participate after understanding the study details.
Be a male or female aged between 40 and 79 years old.
Have an increased risk for a first major cardiovascular event (like a heart attack or stroke) but have not had one before. This can be shown by:
Evidence of coronary artery disease (narrowing of the heart’s blood vessels) seen on a CT scan or coronary angiogram, with specific levels of narrowing.
A coronary artery calcium score of 100 or more, determined by a CT scan at any time before the study starts.
A high 10-year risk of cardiovascular disease of 20% or more.
An intermediate 10-year risk of cardiovascular disease between 7.5% and 20%, with at least two additional risk factors.
If you are on lipid-lowering therapy (medication to lower cholesterol), the dose should be stable for at least 4 weeks before the study starts, and you should be willing to continue this therapy throughout the study.
Your LDL cholesterol level should be between 70 mg/dL (1.81 mmol/L) and 190 mg/dL (4.91 mmol/L) at the start of the study. LDL cholesterol is often called “bad” cholesterol.
Who Cannot Join the Study?
Patients who have had a heart attack or stroke in the past.
Patients with a history of severe allergic reactions to medications.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
Inclisiran is a medication used in this clinical trial to help prevent serious heart-related problems in people who are at high risk. It works by lowering the levels of bad cholesterol in the blood. Cholesterol is a type of fat that can build up in your blood vessels and lead to heart attacks or strokes. Inclisiran helps reduce this risk by blocking a specific protein in the liver, which in turn lowers cholesterol levels. This medication is being tested to see if it can effectively reduce the chances of having major heart events like heart attacks, strokes, or the need for urgent heart procedures.
Atherosclerotic Cardiovascular Disease (ASCVD) – Atherosclerotic cardiovascular disease is a condition characterized by the buildup of fatty deposits, known as plaques, within the walls of arteries. This buildup leads to the narrowing and hardening of the arteries, which can restrict blood flow. Over time, the reduced blood flow can cause various complications, including chest pain, heart attacks, and strokes. The disease progresses as plaques continue to accumulate, potentially leading to complete blockage of the arteries. This can result in significant damage to the heart and other organs due to insufficient blood supply. The progression of ASCVD is influenced by factors such as high cholesterol, high blood pressure, smoking, and diabetes.
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