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 study about?

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.

Who Can Join the Study?

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 Study?

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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Klinikum Coburg GmbH	Coburg	Germany
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
HELIOS Klinikum Erfurt GmbH	Erfurt	Germany
Marienhaus Klinikum St. Elisabeth Neuwied	Neuwied	Germany
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Herzzentrum Leipzig GmbH	Leipzig	Germany
Tolna Vármegyei Balassa János Kórház	Szekszard	Hungary
University Of Debrecen	Debrecen	Hungary
University Teaching Hospital Markusovszky	Szombathely	Hungary
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Semmelweis University	Budapest	Hungary
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
University Of Pecs	Pecs	Hungary
Ufwxbrnwbgkndhcgsplsu Elevm Aro	Essen	Germany
Oqxffprot Kbzowiex Ggra	Hennigsdorf	Germany
Brqojygaze Ipvweacufwag Bffgq Ibxdyrrigzdel Kssgge	Budapest	Hungary
Ceqjot Hzxlsvsvvff Rrmjyozb Uuoqrncxatlvf Dh Tlctj	Tours	France
Ubmmfctzkxywtl Cvwyqwx Kaemafwfu	Gdansk	Poland
Bqgqeawkcjtida Amvsac Sruxrvbhjk	Balatonfured	Hungary
Flobvepxh Pplg Lb Ioqbojvohajew Bjwixkzpq Dvf Hnohiacu Ujqdadibwqjmi Ls Pfn	Madrid	Spain
Kkftgcwvm Sgozdtg Sdsxxoxnvaxsnfx in Jdxs Pglnu Ib	Cracow	Poland

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2026
Germany	Recruiting	01.03.2026
Hungary	Recruiting	01.03.2026
Poland	Recruiting	01.03.2026
Spain	Recruiting	01.03.2026

Trial locations

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.

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.

Trial ID:

2025-521670-34-00

Protocol code:

CKJX839A12309

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?