Study on Evolocumab for Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

3 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called evolocumab, also known by its code name AMG145, in patients who have experienced an acute myocardial infarction, commonly known as a heart attack. The study aims to compare the effectiveness of evolocumab, administered as a solution for injection, with standard treatment strategies in achieving specific cholesterol level goals. The main goal is to see if evolocumab can help reduce levels of LDL cholesterol, often referred to as “bad” cholesterol, by at least 50% and reach a target level of less than 1.4 mmol/L (or 55 mg/dL) over a period of 12 months.

Participants in the study will be randomly assigned to receive either evolocumab or the usual care strategies. The study will follow participants for up to 36 months, with regular check-ups to monitor cholesterol levels and other health indicators. These check-ups will occur at various intervals, including 6 weeks, 22 weeks, and 12 months after starting the treatment, and may continue up to 24 months or longer, depending on the availability of data. The study will also look at how quickly participants can reach their target cholesterol levels and any changes in other types of cholesterol and fats in the blood.

The purpose of this study is to determine if evolocumab is more effective than standard treatments in helping patients who have had a heart attack achieve healthier cholesterol levels, which could potentially reduce the risk of future heart-related problems. By participating in this study, researchers hope to gather valuable information that could improve treatment strategies for managing cholesterol levels in patients with heart disease.

1 joining the trial

Upon joining the trial, informed consent is obtained in writing. This confirms understanding and agreement to participate in the study.

2 initial assessment

An initial assessment is conducted to confirm eligibility. This includes a diagnosis of acute myocardial infarction (heart attack) and other specific criteria.

Eligibility criteria include being male or female, having a diagnosis of STEMI or NSTEMI, and meeting certain health conditions such as diabetes or previous heart conditions.

3 randomization

Participants are randomly assigned to receive either the medication evolocumab or standard care. This process is called randomization.

4 medication administration

If assigned to the evolocumab group, the medication is administered as a subcutaneous injection using a pre-filled pen. The dosage is 140 mg.

The frequency and duration of administration are determined by the study protocol and will be explained during the trial.

5 follow-up visits

Follow-up visits are scheduled at 6 weeks, 22 weeks, and 12 months after randomization. Additional visits may occur at 16, 20, 28, and 32 months if data are available.

During these visits, LDL-C (a type of cholesterol) levels are assessed to monitor progress.

6 end of trial

The trial aims to demonstrate a reduction in LDL-C levels by at least 50% from baseline and achieve a target LDL-C level of less than 1.4 mmol/L at 12 months.

The trial is estimated to end by September 29, 2026.

Who Can Join the Study?

  • Must be male or female.
  • Must have a diagnosis of STEMI (a type of heart attack) defined as:
    • Symptoms of a heart attack lasting at least 30 minutes.
    • Occurred within the previous 24 hours.
    • New persistent ST-segment elevation (a specific change seen on an ECG test) of at least 1 mm in 2 or more continuous ECG leads.
    • Need for a procedure called primary PCI (a treatment to open blocked heart arteries).
    • Must be over 55 years old.
  • Or, must have a non-ST-segment elevation myocardial infarction (NSTEMI) (another type of heart attack) defined by:
    • Angiography (an imaging test of the heart’s blood vessels) performed within 72 hours.
    • Need for a procedure called percutaneous coronary intervention (a treatment to open blocked heart arteries).
    • Having at least one of the following risk factors:
      • Diabetes.
      • Peripheral arterial disease (narrowing of the blood vessels outside of the heart).
      • Multitruncular disease (disease affecting multiple large blood vessels) confirmed by angiography.
      • Previous heart attack or stroke without lasting effects before joining the study.
      • eGFR creatinine clearance (a measure of kidney function) between 15 to 45 mL/min/1.73 m² calculated using the MDRD formula at the time of joining the study.
  • Must be taking a statin (a type of medication to lower cholesterol) at the highest dose they can tolerate as part of their standard treatment, with the intention to start this treatment as soon as possible when joining the study.
  • Must provide written informed consent at the time of joining the study.

Who Cannot Join the Study?

  • Patients who have had a recent acute myocardial infarction (a heart attack) cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
University Hospital Jena KöR Jena Germany
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Centre Hospitalier De Colmar Colmar France
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Les Hopitaux De Chartres Le Coudray France
Azienda Sanitaria Locale Di Pescara Pescara Italy
Herzzentrum Leipzig GmbH Leipzig Germany
Clinique Du Pont De Chaume Montauban France
Centre Hospitalier De Haguenau Haguenau France
Azienda USL Toscana Sud Est Arezzo Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier D’Antibes Juan Les Pins Antibes France
Slaskie Centrum Chorob Serca W Zabrzu Zabrze Poland
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Bydgoszcz Poland
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Hospital Alvaro Cunqueiro Vigo Spain
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier De Pau Pau France
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Azienda Ospedaliero-Universitaria Sant’Anna Ferrara Italy
Ahryrdu Spjdkjlqo Lickgg Tdj Rivoli Italy
Hhtuqept Uoaxomvigmgyc Migozyb Dd Vrypsenlkz Santander Spain
Smyheqoaxdirpvidn Hmqtgkwfd Lj Sbqrxip Aghb Lgseomv La Spezia Italy
Oaykwteg Sbv Dgchum Arezzo Italy
Sgijdeq Usfdfktblawix W Kgpfwywj Cracow Poland
Bnkxomfa Uknxyavycb Hfirhdrk Clamsm Besançon France
Cvivle Hvbuauohfrl Rhyiozcn Uvtkbeudlqkde Du Tfhux Tours France
Cgxs Dq Nubbs Vandoeuvre Les Nancy France
Hbklvlbo Dk La Sjqtg Cgpz I Scce Ple Barcelona Spain
Cppztp Hhaabrdgdpp Rpmpokvz Dfjoxrdwedilmd Angers France
Kknwwnuqn Sowzczy Scaaiilxrykmdsl ii Jwgv Pfwdi Io Cracow Poland
Hwxxthti Utroxgwcwtejia Sdchbymeto &sbyevf Hglunzh dq Htjqkcmxirt STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
29.09.2021
Germany Germany
Recruiting
29.09.2021
Italy Italy
Recruiting
29.09.2021
Poland Poland
Recruiting
29.09.2021
Spain Spain
Recruiting
29.09.2021

Trial locations

Investigated drugs:

Evolocumab is a medication used in this clinical trial to help lower levels of LDL cholesterol, which is often referred to as “bad” cholesterol. It works by blocking a protein in the liver that is responsible for controlling the amount of cholesterol in the blood. By doing this, evolocumab can help reduce the risk of heart-related problems. In this trial, the goal is to see if evolocumab is better than the usual treatments in significantly lowering LDL cholesterol levels over a period of 12 months.

Investigated diseases:

Acute Myocardial Infarction – Acute myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This blockage is often due to a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. As the plaque breaks, a blood clot forms, which can obstruct the flow of blood. The progression of the disease involves the death of heart muscle tissue due to the lack of oxygen-rich blood. Symptoms may include chest pain, shortness of breath, and other discomforts. Over time, the heart’s ability to pump blood effectively can be compromised, leading to further complications.

Trial ID:
2024-518195-31-00
Protocol code:
APHP201075
NCT ID:
NCT04951856
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of ranolazine in patients with ST-elevation heart attack and multiple blocked coronary arteries to improve small blood vessel function

    Recruiting

    2 1 1 1
    Investigated drugs:
    Italy
  • A study evaluating the effect of methylprednisolone compared to sodium chloride in patients with a heart attack

    Recruiting

    3 1 1
    Denmark