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Study of the efficacy and safety of inclisiran and a drug combination in patients with acute coronary syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the effectiveness and safety of starting a treatment called inclisiran early during a hospital stay for patients experiencing acute coronary syndrome. This term refers to a range of sudden medical conditions, such as a ST-elevation myocardial infarction or a non-ST-elevation myocardial infarction, which are commonly known as different types of heart attacks. The research focuses on how this medication works alongside standard care to lower LDL-C, which is often called "bad cholesterol."

During the study, participants may receive inclisiran via a subcutaneous injection, which is a needle shot just under the skin, or a placebo. In addition to the study medication, participants will continue to take background treatments, which include medications like rosuvastatin or atorvastatin. These are types of statins used to manage cholesterol levels. The study will monitor various changes in blood levels, including PCSK9, apoB, VLDL, and triglycerides, to understand how the treatment affects the body over time.

The course of the study involves monitoring participants from the time they are in the hospital through a period of 150 days. Medical professionals will observe how the different treatments influence cholesterol levels and check for any side effects that may occur during the treatment period.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Background medication administration
You will continue taking background medications to manage your condition. these medications are taken by mouth.
The background medications include atorvastatin at a dose of 80 mg or rosuvastatin at a dose of 40 mg.
Step 2
Study treatment initiation
You will receive a subcutaneous injection, which is an injection administered under the skin, either before or at the time of discharge from the hospital.
You will receive either inclisiran at a dose of 300 mg or a placebo, which is an inactive substance that looks like the medication but has no medicinal effect.
Step 3
Monitoring and follow-up
Your low-density lipoprotein cholesterol (LDL-C) levels, which is often called bad cholesterol, will be measured to track changes.
Measurements will be taken to evaluate the percent change and absolute change in your cholesterol levels at specific intervals, including day 30, day 90, and day 150.
Other blood markers, such as PCSK9 (a protein that affects cholesterol), apoB, VLDL, non-HDL cholesterol, HDL cholesterol (often called good cholesterol), total cholesterol, and triglycerides, will also be monitored throughout the study period up to day 150.
Any adverse events, which are any unwanted medical occurrences or side effects, will be recorded during the treatment period.

Who can join the trial?

12 criteria

You must sign a consent form, which is a document where you agree to take part in the study after understanding all the details.
You must be a male or female who is 18 years of age or older.
You must be able to understand what is required for the study and follow the study rules.
You must have been hospitalized for acute coronary syndrome, which is a sudden medical condition where blood flow to the heart is reduced, such as a heart attack (specifically types called STEMI or NSTEMI).
You must be receiving treatment for your heart condition through either medicine alone or through percutaneous coronary revascularization, which is a procedure used to open blocked heart arteries.
If you require a PCI (a procedure where a tiny tube is used to open a blocked artery, sometimes placing a small mesh tube called a stent), it must have been successful.
Your LDL-C (often called "bad cholesterol") levels must meet specific amounts depending on your previous medication history:
If you have been taking high-intensity statins (a type of medicine used to lower cholesterol) for at least 4 weeks, your LDL-C must be 70 mg/dL or higher.
If you have been taking low or moderate-intensity statins for at least 4 weeks, your LDL-C must be 100 mg/dL or higher.
If you have not taken statins for at least 4 weeks or have never taken them, your LDL-C must be 125 mg/dL or higher.
Your fasting LDL-C (your cholesterol level measured after not eating for a period of time) must be at least 70 mg/dL at the start of the study.
You must be assigned to a study group through randomization (a process where participants are assigned to groups by chance, similar to a coin toss) within 7 days of being admitted to the hospital and before or at the time you are discharged.

Who cannot join the trial?

15 criteria

You are medically unstable during your hospital stay for a recent heart attack (a sudden blockage of blood flow to the heart), specifically if you experience low blood pressure (blood pressure that stays below 90/60) caused by heart failure that requires medication to help the heart pump.
You have experienced dangerous heart rhythm problems (irregular heartbeats such as ventricular tachycardia or flutter) within 24 hours before joining the study.
You are in cardiogenic shock (a condition where the heart suddenly cannot pump enough blood to meet the body's needs) or have physical damage to the heart structure caused by a heart attack.
You have NYHA Class IV heart failure, which is the most severe stage of heart failure where symptoms occur even while resting.
Your left ventricular ejection fraction (a measurement of how much blood the heart pumps out with each beat) is less than 20%.
You have uncontrolled high blood pressure (blood pressure higher than 180/110) that does not improve even with medicine.
You currently have or have a history of myopathy (a disease that causes muscle weakness or damage).
Your CK levels (a type of enzyme found in the blood that indicates muscle damage) are 5 times higher than the upper limit of normal (the highest level considered healthy by a lab).
You have had or are scheduled to have CABG (a surgery known as bypass surgery to improve blood flow to the heart).
You have active liver disease, which includes infections, tumors, or metabolic issues in the liver, or if your liver enzymes (ALT, AST, or bilirubin) are significantly higher than normal levels.
You have renal insufficiency (kidney problems), specifically an eGFR (a measure of how well your kidneys filter waste) of less than 30.
Your triglycerides (a type of fat found in your blood) are higher than 400 mg/dL while fasting.
The doctor believes you might reach your target LDL-C (often called "bad" cholesterol) level of less than 55 mg/dL using only standard cholesterol medication for four weeks.
You have a medical history of secondary hypercholesterolemia (high cholesterol caused by another medical condition or medication) or homozygous familial hypercholesterolemia (a rare genetic condition that causes very high cholesterol levels).
You are currently undergoing apheresis (a process where blood is taken out of the body, filtered to remove specific substances, and then returned to the body).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Regional Universitaire De Tours
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Tours, France
Centre Hospitalier Universitaire De Montpellier
Verified
Montpellier, France
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
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Madrid, Spain

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Investigated drugs

Inclisiran
is a medication given as an injection under the skin. It is being tested to see how well it helps lower "bad" cholesterol levels in patients who have experienced a heart-related event.
Rosuvastatin
is a pill taken by mouth that is used as part of the standard care to help manage cholesterol levels.
Atorvastatin
is a pill taken by mouth that is used as part of the standard care to help manage cholesterol levels.

What is already known about the treatment

Rosuvastatin
This medication is a widely used oral treatment belonging to a class of drugs known as statins. It is primarily used to lower high cholesterol levels and reduce the risk of heart disease and stroke. At a molecular level, it works by blocking a specific enzyme in the liver that is responsible for producing cholesterol.
Atorvastatin
This is a common oral medication classified as a statin that is used to manage high cholesterol and prevent cardiovascular issues. It works by inhibiting a key enzyme in the liver, which stops the body from creating large amounts of cholesterol. This drug is well-established in medical practice for treating patients at risk of heart attacks or strokes.
Inclisiran
This medication is an advanced therapy administered via subcutaneous injection to help lower high cholesterol levels. It is a newer type of drug that works by interfering with the instructions our cells use to produce a protein that increases cholesterol. By blocking this process at the genetic messenger level, it helps significantly reduce the amount of bad cholesterol in the blood.

Investigated diseases

Acute coronary syndrome - This condition occurs when blood flow to the heart muscle is suddenly and severely reduced. It is often caused by a blockage in one of the coronary arteries. The condition can manifest as a complete blockage or a partial obstruction of blood flow. This interruption can lead to damage to the heart tissue due to a lack of oxygen. The progression depends on the severity and duration of the reduced blood flow.