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Study on Adjusting Clopidogrel and Prasugrel Dosage for Patients with Chronic Coronary Syndrome Based on Body Weight

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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 treatment of chronic coronary syndrome, a condition where the heart's blood supply is restricted due to narrowed arteries. The study will explore the use of two medications: Clopidogrel, known by the brand name Plavix, and Prasugrel, known by the brand name Efient. Both medications are taken as film-coated tablets and are used to prevent blood clots, which can lead to heart attacks or strokes.

The purpose of the study is to determine if adjusting the dosage of Clopidogrel based on a patient's body weight or Body Mass Index (BMI) can improve treatment outcomes. Patients with low, normal, or high body weight/BMI will be included to see if the medication works better when the dose is tailored to their body size. The study will also compare the effects of Clopidogrel and Prasugrel in patients with high body weight/BMI.

Participants will take the medication orally and will be monitored for changes in their blood's ability to clot, using a test called VerifyNow. The study will also look at other factors, such as genetic differences that might affect how the medication works, and will track any major health events like heart attacks, strokes, or bleeding. The trial aims to provide insights into optimizing treatment for patients with chronic coronary syndrome based on their individual characteristics.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing consent through a signed informed consent form.
Eligibility requires being 18 years or older and currently treated for chronic coronary syndrome with clopidogrel 75 mg once daily (QD) for at least one month.
Step 2
Initial assessment
An initial assessment is conducted to evaluate body weight and Body Mass Index (BMI).
Platelet reactivity is measured using the VerifyNow system to establish a baseline.
Step 3
Medication adjustment
The dosage of clopidogrel may be adjusted based on body weight and BMI.
Participants may continue with clopidogrel 75 mg or switch to prasugrel 10 mg, both administered orally as film-coated tablets.
Step 4
Ongoing monitoring
Regular monitoring of platelet reactivity is conducted to assess the effectiveness of the treatment.
The VerifyNow system is used to measure platelet reaction units (PRU).
Step 5
Genetic testing
Genetic testing may be performed to determine if the CYP2C19 genotype affects platelet reactivity.
This helps in understanding the response to the treatment in different genetic profiles.
Step 6
Evaluation of outcomes
Primary outcomes include the level of platelet reactivity.
Secondary outcomes involve assessing the impact of treatment on various health events such as myocardial infarction, stent thrombosis, revascularization, stroke, and bleeding.
Step 7
Completion of the study
The study is estimated to conclude by February 1, 2026.
Final assessments will be conducted to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

7 criteria

Patients must be **18 years of age or older**. This means you need to be at least 18 years old to participate.
Both **men and women** can participate in the study.
Patients must be treated for **chronic coronary syndrome**. This is a long-term heart condition that affects blood flow to the heart.
Patients must be taking **clopidogrel 75mg** once a day. Clopidogrel is a medication that helps prevent blood clots.
Patients must also be taking **aspirin 100mg** once a day. Aspirin is another medication that helps prevent blood clots.
Patients must have been taking **clopidogrel 75mg for at least one month**. This means you need to have been on this medication for a minimum of one month before joining the study.
Patients must give their **consent** by signing an informed consent form. This means you agree to participate in the study and understand what it involves.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with chronic coronary syndrome. This is a condition where the heart's blood supply is reduced due to narrowed arteries.
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.
Patients who do not meet the specific body weight or Body Mass Index (BMI) requirements. BMI is a measure that uses height and weight to estimate body fat.
Patients who cannot have their platelet reactivity measured using the VerifyNow test. This test checks how well blood cells called platelets are working.

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St. Antonius Ziekenhuis
Nieuwegein, The Netherlands

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Investigated drugs

Clopidogrel is a medication used to prevent blood clots in patients with coronary artery disease. In this clinical trial, the goal is to see if adjusting the dosage of clopidogrel based on a patient's body weight or Body Mass Index (BMI) can improve its effectiveness. The trial will measure how well clopidogrel works by checking platelet reactivity, which is a way to see how well the blood is being prevented from clotting.

What is already known about the treatment

Clopidogrel – Clopidogrel is administered orally in tablet form and is widely used in the medical field, particularly for its role in preventing blood clots. It is currently being studied in clinical trials to optimize its dosage based on body weight or Body Mass Index (BMI) in patients with coronary artery disease. The main therapeutic indication for clopidogrel is to reduce the risk of heart attack and stroke in individuals with chronic coronary syndrome. At the molecular level, clopidogrel works by inhibiting platelet aggregation, which prevents the formation of clots. It belongs to the pharmacological class of antiplatelet agents.

Investigated diseases

Chronic Coronary Syndrome – This condition is characterized by the narrowing or blockage of the coronary arteries, which supply blood to the heart muscle. It often results from the buildup of fatty deposits, known as plaques, on the artery walls. Over time, this can lead to reduced blood flow to the heart, causing symptoms such as chest pain or discomfort, especially during physical activity or stress. The disease progresses slowly and can lead to more severe heart problems if the blood flow becomes significantly restricted. It is a long-term condition that requires ongoing management to prevent complications.