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

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What is this study about?

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.

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.

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.

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.

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).

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	26.04.2023

Trial locations

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.

Investigated diseases:

Chronic coronary syndrome

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.

Trial ID:

2024-518890-33-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?