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Study on Reducing Bleeding Risk in Heart Attack Patients Using Clopidogrel, Ticagrelor, and Prasugrel After Stent Procedure

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 patients who have experienced a myocardial infarction, commonly known as a heart attack. The study is exploring a new approach to treatment for those at high risk of bleeding. The treatment involves a combination of medications known as dual antiplatelet therapy (DAPT), which helps prevent blood clots. The medications being studied include ticagrelor (Brilique), prasugrel (Efient, Prasugrel Mylan, Prasugrel Teva, Prasugrel "Krka"), clopidogrel, and acetylsalicylic acid (commonly known as aspirin). These medications are taken orally in the form of film-coated tablets.

The purpose of the study is to see if patients with a heart attack who are at high risk of bleeding can safely switch to a personalized, less intense DAPT strategy. This involves using clopidogrel and a shorter duration of DAPT, guided by a genetic test called Cytochrome P2C19-genotyping. The goal is to reduce bleeding without increasing the risk of further heart problems. Participants in the study will be randomly assigned to different treatment groups, which may include a placebo, and will be monitored over a period of time to assess the safety and effectiveness of the treatment strategies.

The trial will track several outcomes, including the occurrence of any major health events such as death, another heart attack, or stroke, as well as any significant bleeding events. The study aims to provide valuable information that could improve treatment strategies for heart attack patients who are at high risk of bleeding, potentially leading to safer and more effective care options in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be informed about the study's purpose, which is to assess a new approach to dual antiplatelet therapy (DAPT) for patients with myocardial infarction who are at high risk of bleeding.
You will be asked to provide consent to participate in the study after understanding the potential risks and benefits.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have had a myocardial infarction treated with percutaneous coronary intervention (PCI) and that you meet other specific criteria.
Your medical history and current health status will be reviewed, and necessary tests will be performed.
Step 3
Medication allocation
You will be allocated to a treatment group. The trial involves the use of different medications, including ticagrelor, prasugrel, clopidogrel, and acetylsalicylic acid, all administered orally in the form of film-coated tablets.
The specific medication and dosage will be determined based on your individual needs and the study protocol.
Step 4
Treatment phase
During the treatment phase, you will take the assigned medication as directed. The frequency and duration of administration will be specified by the study team.
Regular follow-up visits will be scheduled to monitor your response to the treatment and to ensure your safety.
Step 5
Monitoring and follow-up
Throughout the trial, your health will be closely monitored. This includes regular check-ups and tests to assess the effectiveness of the treatment and to identify any side effects.
You will be asked to report any new symptoms or concerns to the study team promptly.
Step 6
Completion of the trial
At the end of the trial, a final assessment will be conducted to evaluate the outcomes of the treatment.
You will receive information about the results of the study and any further steps, if necessary.

Who can join the trial?

10 criteria

You must have had a myocardial infarction (heart attack) caused by a condition called atherothrombotic coronary artery disease (Type 1 MI). This means your heart attack was due to a blockage in the heart's blood vessels.
Your heart attack must have been treated with a procedure called percutaneous coronary intervention (PCI), which involves placing a small tube called a stent in the heart's blood vessels to keep them open.
Your heart attack must meet certain medical criteria, such as a rise or fall in a blood test called cardiac troponin, which shows heart muscle damage. Additionally, you must have at least one of the following:
Symptoms that suggest a heart problem, like chest pain.
New changes on an electrocardiogram (ECG), a test that records the heart's electrical activity.
Development of new Q-waves on the ECG, which can indicate heart damage.
Imaging tests showing new heart muscle damage or abnormal heart movement.
A visible blood clot in the heart's blood vessels seen during an imaging test called angiography.
You must have a PRECISE-DAPT score of 25 or higher. This score helps determine your risk of bleeding while on certain heart medications.
You must be at least 18 years old.

Who cannot join the trial?

5 criteria

Patients who have had a myocardial infarction (heart attack).
Patients who are at high risk of bleeding.
Patients who cannot safely use a personalized treatment plan involving clopidogrel (a medication that helps prevent blood clots).
Patients who cannot undergo Cytochrome P2C19-genotyping (a test to see how your body processes certain medications).
Patients who cannot have a shorter duration of dual antiplatelet therapy (DAPT), which is a treatment involving two medications to prevent blood clots.

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Verified sites

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Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Odense University Hospital
Odense, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Clopidogrel is a medication used to prevent blood clots in people who have had a heart attack or other heart-related issues. In this trial, it is part of a strategy to reduce the risk of bleeding in patients who are at high risk. The trial is testing if using clopidogrel, along with a genetic test to see how well your body can process the drug, can help safely reduce the amount of time patients need to be on dual antiplatelet therapy, which is a combination of two medications that prevent blood clots.

What is already known about the treatment

Clopidogrel – Clopidogrel is a medication taken orally, usually in the form of a tablet, and is used to prevent blood clots in patients who have had a heart attack, specifically those treated with a procedure called percutaneous coronary intervention. It is currently being studied in clinical trials to see if it can be used in a safer way for patients who are at high risk of bleeding. The main use of clopidogrel is to reduce the risk of further heart problems by preventing platelets, which are small blood cells, from sticking together and forming clots. It works by blocking a specific receptor on the platelets, which is part of a larger group of medications known as antiplatelet drugs.

Investigated diseases

Myocardial infarction – 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. Symptoms may include chest pain, shortness of breath, and discomfort in the upper body. Over time, this can lead to complications such as heart failure or arrhythmias.