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Study on Controlling Coronary Risk Factors and Platelet Aggregation Using Ramipril, Acetylsalicylic Acid, and Atorvastatin Calcium Trihydrate in Patients with Heart Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the management of risk factors related to heart disease, specifically looking at how well certain medications can control blood pressure and cholesterol levels. The study involves a treatment called the Trinomia polypill, which is a combination of three medications: ramipril, acetylsalicylic acid (commonly known as aspirin), and atorvastatin calcium trihydrate. These medications are used to help manage blood pressure, prevent blood clots, and lower cholesterol, respectively. The trial will also involve the use of these medications separately to compare their effectiveness.

The purpose of the study is to analyze the level of systolic blood pressure (the top number in a blood pressure reading) and LDL cholesterol (often referred to as "bad" cholesterol) in the same patient during two different periods. One period involves treatment with the Trinomia polypill for three months, and the other involves treatment with the individual components for three months. This approach helps to understand how the combination pill compares to taking the medications separately.

Participants in the study will take the medications orally, as they are available in capsule or tablet form. The study will last for a total of six months, with patients switching between the polypill and the separate medications. The trial aims to provide insights into the best way to manage heart disease risk factors, potentially improving treatment strategies for patients with ischemic heart disease, a condition where the heart's blood supply is reduced due to narrowed arteries.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Begin treatment with the Trinomia polypill. This medication is taken orally in the form of a hard capsule.
The polypill contains three active substances: ramipril, acetylsalicylic acid, and atorvastatin calcium trihydrate.
This phase lasts for 3 months, during which the polypill is taken daily as prescribed.
Step 2
First evaluation
After 3 months of treatment with the polypill, an evaluation is conducted to measure systolic blood pressure and LDL cholesterol levels.
This evaluation helps to assess the effectiveness of the polypill in controlling coronary risk factors.
Step 3
Separate components treatment phase
Switch to taking the components of the polypill separately. This involves taking ramipril, acetylsalicylic acid, and atorvastatin as individual medications.
Each medication is taken orally, following the prescribed dosage and frequency.
This phase also lasts for 3 months, with daily administration of each medication.
Step 4
Second evaluation
After completing the 3-month period of taking the components separately, another evaluation is conducted.
This evaluation again measures systolic blood pressure and LDL cholesterol levels to compare with the results from the polypill phase.
Step 5
Final analysis
The results from both treatment phases are analyzed to determine the level of control over coronary risk factors and platelet aggregation.
This analysis helps to understand the effectiveness of the polypill compared to taking the components separately.

Who can join the trial?

5 criteria

Patients must be **over 18 years of age**.
Patients should have **ischemic heart disease**, which is a condition where the heart doesn't get enough blood and oxygen.
Patients must be currently receiving treatment with the **Trinomia® polypill** for secondary prevention. This means they are taking a specific medication to help prevent further heart problems.
Patients need to be able to attend **6 visits** required to complete the study.
Patients must sign the **Informed Consent**, which is a document that explains the study and confirms their agreement to participate.

Who cannot join the trial?

4 criteria

Patients who have uncontrolled **coronary risk factors**. This means that the factors that increase the risk of heart disease, like high blood pressure or high cholesterol, are not well managed.
Patients with issues related to **platelet aggregation**. Platelets are small blood cells that help with clotting, and aggregation refers to them clumping together. Problems here could mean a higher risk of blood clots.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Investigated drugs

Trinomia
This is a combination medication, often referred to as a polypill, used in the trial to manage risk factors such as high blood pressure and cholesterol. It combines multiple active ingredients into a single pill to simplify treatment and improve adherence. The goal is to control systolic blood pressure and LDL cholesterol levels effectively.
Aspirin
This medication is used to prevent blood clots, which can reduce the risk of heart attacks and strokes. It works by inhibiting the function of platelets, which are small blood cells that clump together to form clots.
Atorvastatin
This is a medication used to lower cholesterol levels, specifically LDL cholesterol, which is often referred to as "bad" cholesterol. By reducing cholesterol levels, it helps prevent heart disease and stroke.
Ramipril
This medication is used to treat high blood pressure and heart failure. It works by relaxing blood vessels, which allows blood to flow more easily and reduces the workload on the heart.

What is already known about the treatment

Trinomia – Trinomia is administered orally in the form of a polypill, which combines multiple medications into a single pill. It is currently being studied in clinical trials to assess its effectiveness in controlling coronary risk factors and platelet aggregation. The main therapeutic indications include managing blood pressure and cholesterol levels to reduce cardiovascular risk. At the molecular level, Trinomia works by combining different agents that target various pathways involved in heart disease, such as lowering LDL cholesterol and reducing blood pressure. It is classified pharmacologically as a combination drug used for cardiovascular prevention.

Investigated diseases

Coronary Artery Disease – This condition involves the narrowing or blockage of the coronary arteries, usually due to a buildup of cholesterol and fatty deposits called plaques. Over time, these plaques can harden or rupture, leading to reduced blood flow to the heart muscle. As the disease progresses, it can cause chest pain, shortness of breath, or other symptoms, especially during physical activity or stress. If the blood flow becomes severely restricted, it can lead to a heart attack. The progression of the disease can vary, with some individuals experiencing slow development of symptoms, while others may have rapid changes. Regular monitoring and lifestyle changes can help manage the condition.