Study on the Effect of Evolocumab on Heart Disease in Patients Needing Coronary Angiography

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What is this study about?

This clinical trial is focused on studying the effects of a treatment on patients with atherosclerotic cardiovascular disease, a condition where the blood vessels become narrowed or blocked due to the buildup of fatty deposits. The treatment being tested is a medication called Repatha, which contains the active substance evolocumab. This medication is administered as a solution for injection using a pre-filled pen.

The purpose of the study is to examine how Repatha affects a specific heart condition known as coronary microvascular dysfunction, which involves problems with the small blood vessels in the heart. The study will compare the effects of a single dose of Repatha with no treatment in patients who have been diagnosed with atherosclerotic cardiovascular disease and require a procedure called coronarography, which is an imaging test to look at the heart’s blood vessels.

Participants in the study will receive either the medication or no treatment and will be monitored over a period of four weeks. The study aims to provide insights into how Repatha might help improve the function of the heart’s small blood vessels in patients with this type of heart disease. The results could potentially lead to better treatment options for individuals with atherosclerotic cardiovascular disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, weight, LDL-C level, and the need for coronarography.

Informed consent is required to participate in the study.

2 initial assessment

An initial assessment is conducted to evaluate the current state of coronary microvascular function using noninvasive imaging tests.

This assessment helps establish a baseline for comparison after treatment.

3 treatment administration

A single administration of evolocumab is given as a subcutaneous injection.

The medication used is Repatha 140 mg solution for injection in pre-filled pen.

4 monitoring period

A monitoring period of 4 weeks follows the administration of the medication.

During this time, no additional treatment is provided, allowing for observation of the medication’s effects.

5 follow-up assessment

After 4 weeks, a follow-up assessment is conducted to measure the index of microcirculatory resistance (IMR) during invasive coronary angiography.

Additional parameters such as troponin I levels, coronary angiography parameters, and resting ultrasound parameters are also evaluated.

6 completion of study participation

Upon completion of the follow-up assessment, participation in the study concludes.

Results from the assessments are used to compare the effects of the treatment on coronary microvascular dysfunction.

Who Can Join the Study?

Male or female patient, aged between 40 and 85 years old.
Weighs more than 50 kilograms.
Has an LDL-C level of at least 0.7 grams per liter. LDL-C is a type of cholesterol in the blood, and this level should be from a test done in the last 6 months.
Needs a procedure called coronarography, which is a special X-ray test to see the heart’s blood vessels, as recommended by European guidelines.
Is affiliated with social security, meaning they have access to a government health insurance program.
Has signed an informed consent form, which means they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent heart attack or stroke.
Patients who have severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend study visits.
Patients who have any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CHU Grenoble Alpes	La Tronche	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.01.2021

Trial locations

Investigated drugs:

Evolocumab

Evolocumab is a medication used in this clinical trial to study its effect on coronary microvascular dysfunction in patients with atherosclerotic cardiovascular disease. It is a type of drug known as a PCSK9 inhibitor, which helps to lower cholesterol levels in the blood. The trial aims to see how a single administration of evolocumab affects the small blood vessels in the heart over a period of four weeks.

Atherosclerotic Cardiovascular Disease – This disease involves the buildup of fatty deposits, known as plaques, within the walls of arteries, leading to their narrowing and hardening. Over time, this can restrict blood flow to various organs and tissues, potentially causing symptoms like chest pain or shortness of breath. The progression of the disease can lead to more severe complications, such as heart attacks or strokes, if the blood supply becomes significantly reduced or blocked. The condition often develops slowly over many years and may not present noticeable symptoms until the arteries are significantly affected. Factors such as high cholesterol, high blood pressure, smoking, and diabetes can contribute to the development and progression of atherosclerosis. Regular monitoring and lifestyle changes are crucial in managing the disease’s progression.

Trial ID:

2024-519012-14-00

Protocol code:

38RC19.186

NCT ID:

NCT04338165

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effect of Evolocumab on Heart Disease in Patients Needing Coronary Angiography

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?