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Effect of ramipril, acetylsalicylic acid, and atorvastatin calcium trihydrate plus nurse education on treatment adherence 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 focuses on individuals who have experienced Acute Coronary Syndrome, a term used to describe a sudden decrease in blood flow to the heart that can cause a heart attack. The research aims to evaluate how a combination of a single pill containing multiple medications and a nurse-led education program affects how well patients follow their prescribed medical treatment. The medication being tested is a polypill known as Trinomia, which contains ramipril, acetylsalicylic acid, and atorvastatin. This pill is compared to taking the individual medications, Acovil, Cardyl, and Adiro, separately.

Participants in the study will be assigned to different groups to receive either the combined pill or the individual medications, along with a program where nurses provide educational support. The study will follow these individuals for one year after they are discharged from the hospital to see if this combined approach helps them stay consistent with their daily medication routine. The course of the study involves regular follow-ups to monitor how well the treatment plan is being followed and to observe various health factors.

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
Hospital discharge and medication start
At the time of hospital discharge, one of two medication regimens will be started to treat acute coronary syndrome (a sudden reduction of blood flow to the heart).
The first option is a single polypill called trinomia, which contains ramipril, acetylsalicylic acid, and atorvastatin calcium trihydrate. the dose is 142.50 mg taken in a hard capsule form orally.
The second option consists of three separate medications: acovil (ramipril, 10 mg tablet), cardyl (atorvastatin, 40 mg film-coated tablet), and adiro (acetylsalicylic acid, 100 mg gastro-resistant tablet). these are taken orally.
Step 2
Education program and monitoring
An education program led by a nurse will be provided to assist with the management of the treatment.
Throughout the process, various aspects of health will be monitored, including drug levels in the body, cardiovascular risk factors, quality of life, functional capacity for daily activities, cognitive status, and the ability to perform instrumental activities of daily living (tasks such as managing household chores or finances).
Step 3
One-year follow-up and adherence assessment
one year after the hospital admission, an assessment of therapeutic adherence (how consistently the medication is taken) will be conducted.
This assessment is performed using four specific methods: the morisky green scale, the haynes-sackett scale, attendance at follow-up visits, and the pick-up of medication from the pharmacy.
To ensure an unbiased result, the nursing team performing the evaluation will not know which medication group was assigned.

Who can join the trial?

6 criteria

You must be an adult, which means you are a person who has reached legal adulthood.
You must have been admitted to the hospital for acute coronary syndrome, a term used to describe a sudden blockage or problem with blood flow to the heart.
Your condition must have shown signs of ischemia, which means your heart muscle was not getting enough oxygen-rich blood.
Your condition must have been confirmed by specific changes seen on an electrocardiogram (a test that records the electrical activity of your heart), such as changes in the heart's electrical waves.
Your condition must have been confirmed by an elevated level of troponin, which is a specific protein released into the blood when the heart muscle is damaged.
You must have been admitted to one of the study centers between September 2024 and September 2026.

Who cannot join the trial?

4 criteria

You cannot participate if you have a contraindication, which means a medical reason or allergy that makes it unsafe for you to take any of the medicines included in the polypill.
You cannot join if you are unwilling or unable to provide informed consent, which is the formal agreement to participate in the study after being fully explained all the details and risks.
You cannot participate if you are unable to complete the clinical follow-up, which refers to the scheduled medical check-ups and appointments required throughout the study.
You cannot be part of the study if you are living in a long-term care facility or a nursing home when you join the study or at any point during the one-year period of the research.

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Verified sites

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Bellvitge University Hospital
L'hospitalet De Llobregat, Spain

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Investigated drugs

Trinomia
is a combination pill that contains three different medicines: ramipril, which helps lower blood pressure; aspirin, which prevents blood clots from forming; and atorvastatin, which helps lower cholesterol levels. This pill is being tested to see if taking one combined medication improves how well patients follow their treatment.
Acovil
is a medication containing ramipril, which is used to help manage blood pressure and protect the heart.
Cardyl
contains atorvastatin, a medicine used to lower cholesterol levels in the blood.
Adiro
contains aspirin, which is used to prevent blood clots that could lead to heart problems.

What is already known about the treatment

Ramipril
This medication is taken orally in tablet form and is widely used to treat high blood pressure and protect the heart after a heart attack. It belongs to a group of drugs called ACE inhibitors, which work by blocking a specific enzyme in the body that causes blood vessels to tighten. By relaxing these vessels, the medicine helps blood flow more easily and reduces the workload on the heart.
Acetylsalicylic acid
Taken as an oral tablet, this well-known medicine is commonly used to prevent blood clots in patients with heart conditions. It belongs to a class of drugs called antiplatelets, which work by interfering with the chemical signals that cause blood cells to stick together. This action helps prevent the formation of dangerous clots in the arteries that could lead to a heart attack or stroke.
Atorvastatin
This medication is administered orally as a tablet and is standardly used to lower high cholesterol levels and reduce the risk of heart disease. It is classified as a statin, which works by blocking a specific enzyme in the liver that is responsible for producing cholesterol. By reducing the amount of cholesterol made in the body, it helps prevent the buildup of fatty deposits in the arteries.

Investigated diseases

Acute coronary syndrome - This condition occurs when the blood flow to the heart muscle is suddenly reduced or blocked. It is typically caused by a buildup of fatty substances and other materials in the arteries that supply the heart. This blockage can lead to a sudden decrease in oxygen reaching the heart tissue. The condition can manifest as a variety of related events, such as unstable angina or a heart attack. As the blockage persists, it can cause damage to the heart muscle over time.