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Study on the Effectiveness of Clopidogrel, Prasugrel, and Ticagrelor in Patients with Coronary Acute Syndrome Using VerifyNow Device

Verified siteRegistered drugNo placebo

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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 treatments for Cardiovascular Diseases, specifically in patients with a condition known as Acute Coronary Syndrome (ACS). ACS is a term used for situations where the blood supplied to the heart muscle is suddenly blocked. The study involves three medications: Brilique (ticagrelor), Efient (prasugrel), and Plavix (clopidogrel). These medications are known as antiplatelet agents, which help prevent blood clots by stopping platelets, a type of blood cell, from sticking together.

The purpose of the study is to determine if switching from the more powerful antiplatelet agents, prasugrel and ticagrelor, to clopidogrel, with guidance from a device called VerifyNow, can have a positive effect on treating ACS. The VerifyNow device measures how well platelets are being inhibited, or stopped, from forming clots. Participants in the study will take these medications in the form of film-coated tablets, which are taken orally, meaning they are swallowed. The study will last for up to 12 months, during which time the effects of the medication switch will be monitored.

Throughout the study, researchers will look at the occurrence of certain heart-related events, such as heart attacks, strokes, and bleeding incidents. These are referred to as Net Adverse Cardiac Events (NACE). The study aims to see if the change in medication can reduce these events over a 12-month period. The results will help determine the best approach to using these medications for people with ACS.

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
Joining the study
Upon joining the study, eligibility is confirmed. Participants must be 18 years or older, understand the study, and have provided written consent.
Participants should have experienced an Acute Coronary Syndrome (ACS) and undergone a procedure called Percutaneous Coronary Intervention (PCI) with a specific type of stent. They should be discharged on a combination of medications including Acetylsalicylic Acid and either Ticagrelor or Prasugrel.
Step 2
Initial treatment phase
Participants begin treatment with either Brilique (Ticagrelor) 90 mg or Efient (Prasugrel) 10 mg, both taken orally as film-coated tablets.
The treatment aims to manage platelet activity in the blood, which is crucial for patients with cardiovascular conditions.
Step 3
Treatment adjustment
The study uses a device called VerifyNow® to measure platelet aggregation. This helps determine if a switch to Plavix (Clopidogrel) 75 mg, also taken orally as a film-coated tablet, is beneficial.
The goal is to optimize treatment by potentially reducing the strength of the medication while maintaining effectiveness.
Step 4
Monitoring and follow-up
Participants are monitored for any adverse cardiac events, such as heart attacks or strokes, over a 12-month period.
The study also tracks any bleeding events and other health outcomes related to the heart and blood vessels.
Step 5
Completion of study
The study is expected to conclude by December 2025. At this point, all data regarding the incidence of cardiac events and other health outcomes will be analyzed.
The results will help determine the effectiveness of adjusting medication based on platelet activity measurements.

Who can join the trial?

7 criteria

Patients must be **18 years or older**.
Patients must be able to **understand the nature of the study**.
Patients must have **provided written informed consent**, which means they agree to participate after understanding the study details.
Patients must have **Acute Coronary Syndrome (ACS)**, a condition where the heart doesn't get enough blood.
Patients must have undergone **Percutaneous Coronary Intervention (PCI)**, a procedure to open blocked heart arteries, during their hospital stay.
Patients must have received an **absorbable polymer stent**, a small tube placed in the artery to keep it open.
Patients must have been discharged on **double antiplatelet therapy**, which means taking two medications to prevent blood clots: **Acetylsalicylic Acid (Aspirin)** and either **Ticagrelor** or **Prasugrel**.

Who cannot join the trial?

3 criteria

Patients with certain types of cardiovascular diseases cannot participate. Cardiovascular diseases are conditions that affect the heart and blood vessels.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital De Galdakao Usansolo
Verified
Galdakao, Spain

Trial locations

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Investigated drugs

Prasugrel
is a medication used to prevent blood clots in people with acute coronary syndrome (ACS). It works by making the blood less sticky, which helps to reduce the risk of heart attacks or strokes.
Ticagrelor
is another medication that helps prevent blood clots in patients with ACS. It works similarly to prasugrel by reducing the stickiness of the blood, thereby lowering the chance of heart-related complications.
Clopidogrel
is a medication used to prevent blood clots in people with heart conditions. In this trial, it is used as a less powerful alternative to prasugrel and ticagrelor, with its use guided by a special device to measure platelet activity.

What is already known about the treatment

Prasugrel
Prasugrel is administered orally in tablet form and is used to prevent blood clots in patients with acute coronary syndrome. It is currently well-established in medical practice and literature as an effective antiplatelet medication. The main therapeutic indication for prasugrel is to reduce the risk of heart attack or stroke in patients with heart-related conditions. At the molecular level, prasugrel works by inhibiting platelet activation and aggregation, which are crucial steps in the formation of blood clots. It belongs to the pharmacological class of antiplatelet agents.
Ticagrelor
Ticagrelor is taken orally as a tablet and is used to prevent blood clots in patients with acute coronary syndrome. It is widely recognized in medical literature as a potent antiplatelet drug. The primary therapeutic use of ticagrelor is to lower the risk of heart attack or stroke in individuals with cardiovascular diseases. Ticagrelor functions by blocking a receptor on platelets, preventing them from clumping together and forming clots. It is classified as an antiplatelet agent.
Clopidogrel
Clopidogrel is administered orally in tablet form and is used to prevent blood clots in patients with cardiovascular diseases. It is a well-established medication in the medical community, often used in combination with other treatments. The main therapeutic indication for clopidogrel is to reduce the risk of heart attack or stroke. Clopidogrel works by inhibiting platelet aggregation, thereby preventing clot formation. It is part of the antiplatelet drug class.

Investigated diseases

Cardiovascular Diseases – These are a group of disorders affecting the heart and blood vessels. They can include conditions such as coronary artery disease, which involves the narrowing or blockage of the coronary arteries, and can lead to chest pain or heart attacks. Another example is heart failure, where the heart is unable to pump blood effectively, causing symptoms like shortness of breath and fatigue. Cardiovascular diseases can also involve arrhythmias, which are irregular heartbeats that may cause palpitations or dizziness. Over time, these conditions can lead to complications such as heart attacks or strokes. They often progress due to factors like high blood pressure, high cholesterol, smoking, and a sedentary lifestyle.