Study on Inclisiran and Statin Therapy for Patients with Non-obstructive Coronary Artery Disease to Assess Atherosclerotic Plaque Progression

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What is this study about?

This clinical trial is focused on studying the effects of a medication called inclisiran on a condition known as non-obstructive coronary artery disease. This condition involves the buildup of fatty deposits in the arteries of the heart, which can lead to heart problems. The study will also involve participants who are already taking the highest dose of medications called statins, specifically atorvastatin and rosuvastatin, which are commonly used to lower cholesterol levels. The purpose of the study is to see if adding inclisiran to the current statin therapy can further reduce the buildup of these fatty deposits in the heart’s arteries.

Participants in the study will be randomly assigned to receive either inclisiran or a placebo, which is a substance with no active medication. The study will last for 24 months, during which participants will continue their current statin therapy. The progress of the fatty deposits in the heart will be monitored using a special imaging method called coronary computed tomography angiography (CCTA). This method allows doctors to see detailed images of the heart’s arteries and assess any changes in the buildup of fatty deposits over time.

The main goal of the study is to determine if inclisiran is more effective than the placebo in reducing the total volume of fatty deposits in the heart’s arteries. Additionally, the study will look at changes in cholesterol levels and the volume of specific types of fatty deposits. The safety of inclisiran will also be monitored by recording any side effects or serious health events that occur during the study. Participants will be closely observed to ensure their well-being throughout the trial.

1 joining the study

Upon joining the study, the participant will be required to provide written informed consent.

Eligibility will be confirmed based on specific criteria, including age and fasting LDL-C levels.

2 baseline visit

At the baseline visit, participants must be on a stable dose of maximally tolerated statin therapy for at least four weeks.

A coronary computed tomography angiography (CCTA) scan will be performed to assess the condition of the coronary arteries.

3 statin optimization period

Participants not on maximally tolerated statin therapy will undergo a statin optimization period to adjust their medication.

The goal is to achieve a fasting LDL-C level of at least 55 mg/dL.

4 medication administration

Participants will receive either inclisiran or a placebo, in addition to their statin therapy.

Inclisiran is administered via subcutaneous injection, while statins such as atorvastatin and rosuvastatin are taken orally.

5 follow-up visits

Regular follow-up visits will be scheduled to monitor the participant’s health and the progression of atherosclerotic plaque.

These visits will include assessments of LDL-C levels and other relevant health indicators.

6 final assessment

At the end of the 24-month period, a final CCTA scan will be conducted to evaluate changes in coronary atheroma volume.

The study aims to determine the effectiveness of inclisiran in reducing plaque progression compared to the placebo.

Who Can Join the Study?

You must provide written informed consent before any study assessments are done.
You need to be a male or female between 18 and 80 years old at the time of signing the consent form.
Your fasting LDL-C (a type of cholesterol) level must meet specific criteria based on your current statin therapy:

If you are on statin therapy but not the highest dose you can tolerate, your LDL-C should be 100 mg/dL (2.6 mmol/L) or higher.
If you have never taken statins and have no known intolerance, your LDL-C should be 150 mg/dL (3.9 mmol/L) or higher.
If you are on a stable dose of the highest statin dose you can tolerate or cannot take statins, your LDL-C should be 55 mg/dL (1.4 mmol/L) or higher.

If you are going through a period to optimize your statin therapy, your fasting LDL-C should be 55 mg/dL (1.4 mmol/L) or higher at a specific visit.
You must have Non-obstructive Coronary Artery Disease (NOCAD) without previous heart-related events. This means:

A specific score from a CT scan is greater than 5, and the narrowing of your arteries is less than 50%.
Or, the score is greater than 5, the narrowing is 50% or more, but another test shows a specific value of 0.76 or higher.

At the start of the study, you must be on a stable dose of the highest statin dose you can tolerate for at least 4 weeks. If not, you may need to go through a period to optimize your statin therapy.
Your fasting LDL-C should be 55 mg/dL (1.4 mmol/L) or higher at the start of the study, measured at a central lab.
Your fasting triglycerides (another type of fat in the blood) should be less than 400 mg/dL (4.52 mmol/L) based on lab results at specific visits.

Who Cannot Join the Study?

Patients who have a different heart condition that blocks blood flow in the coronary arteries cannot participate.
Patients who are not taking the highest dose of statin medication they can tolerate are excluded.
Patients who cannot undergo a special heart scan called CCTA, which looks at the heart’s blood vessels, are not eligible.
Patients who are not within the specified age range for the study cannot join.
Patients who are part of a vulnerable group, meaning they might need extra protection or care, are not allowed to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
AZ Turnhout	Turnhout	Belgium
Ospedale Galeazzi S.p.A.	Milan	Italy
University Hospital Galway	Galway	Ireland
Hospital General Universitario De Valencia	Valencia	Spain
Jessa Ziekenhuis	Hasselt	Belgium
Ziekenhuis Oost Limburg	Genk	Belgium
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
University Of Szeged	Szeged	Hungary
Instituto Medico Quirurgico San Rafael S.A.	A Coruna Galicia	Spain
Azorg	Aalst	Belgium
Ulvuozunyl Hoccmqpfj Pbgxq Scnetbsdcno Crnyjel Fuly	Paris	France
Sczesnhcfp Eeflxyf	Budapest	Hungary
Adfkhdc Ovtxspuabgj Udsmazwgyhjfh Cegijrywvjsq Duayn Sqohsw E Dlhlz Slieqhj Dr Txtrmr	Turin	Italy
Hjtjivyy Dh Lu Smvqw Cpug I Svkz Pvg	Barcelona	Spain
Hxosksoq Vrbh dbmpvjdw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	24.11.2022
France	Not recruiting	24.11.2022
Hungary	Not recruiting	24.11.2022
Ireland	Not recruiting	24.11.2022
Italy	Not recruiting	24.11.2022
Spain	Not recruiting	24.11.2022

Trial locations

Investigated drugs:

Inclisiran is a medication being studied for its ability to reduce the buildup of fatty deposits in the arteries of the heart. It is being tested in people who have coronary artery disease but have not had any heart-related events like heart attacks. The goal is to see if inclisiran can help decrease the amount of plaque in the arteries when used alongside the highest dose of statin therapy that a person can tolerate. This study will use special heart imaging to measure changes in the arteries over a period of 24 months.

Investigated diseases:

Coronary artery disease

Non-obstructive Coronary Artery Disease – This condition involves the presence of plaque in the coronary arteries that does not significantly block blood flow. Unlike obstructive coronary artery disease, the arteries are not narrowed enough to cause major blockages. However, the plaque can still cause symptoms like chest pain or discomfort, especially during physical exertion. Over time, the plaque can become unstable and potentially lead to more serious heart issues. The disease progresses as the plaque accumulates, which can affect the heart’s blood supply. Monitoring and lifestyle changes are often necessary to manage the condition.

Trial ID:

2024-511126-31-00

Protocol code:

CKJX839D12303

NCT ID:

NCT05360446

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Inclisiran and Statin Therapy for Patients with Non-obstructive Coronary Artery Disease to Assess Atherosclerotic Plaque Progression

What is this study about?

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