Study on Personalized Anti-Platelet Therapy with Prasugrel, Clopidogrel, and Ticagrelor for Patients with Stable Coronary Artery Disease Undergoing Stenting

3 1 1 1

What is this study about?

This clinical trial is focused on patients with coronary artery disease, a condition where the blood vessels supplying the heart become narrowed or blocked. The study is particularly interested in those undergoing a procedure called percutaneous coronary intervention, which involves placing a small tube, or stent, to help keep the blood vessels open. The trial will explore the effects of different medications used to prevent blood clots in these patients. The medications being studied include Efient (prasugrel), Plavix (clopidogrel), Brilique (ticagrelor), and Aspirin (acetylsalicylic acid). These medications are known as anti-platelet drugs, which help prevent platelets, a type of blood cell, from clumping together and forming clots.

The purpose of the study is to determine if using a personalized approach to choosing these medications, based on a person’s genetic makeup, can improve the effectiveness of the treatment. This involves using a genetic test to guide the selection of the most suitable anti-platelet drug for each patient. The study will compare this personalized approach to the standard treatment, which typically involves using a combination of two anti-platelet drugs. The main focus will be on how well the medications prevent platelets from clumping together, which is measured using a test called the VerifyNow system.

Participants in the study will be randomly assigned to either the personalized treatment group or the standard treatment group. The study will last for about six months, during which time the effectiveness and safety of the treatments will be monitored. This includes checking for any bleeding complications and other heart-related events. The goal is to find out if the personalized approach can provide better protection against blood clots while minimizing the risk of bleeding.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This is a document that confirms your understanding of the study and your willingness to participate.

You must be at least 18 years old and have a condition known as chronic coronary syndrome. You will also need to have undergone a successful elective procedure called percutaneous coronary intervention.

2 randomization

After joining, you will be randomly assigned to one of two groups. One group will receive a treatment based on genetic testing, and the other will receive standard treatment.

This process is called randomization and ensures that the study results are unbiased.

3 medication administration

You will be given one of the following medications: Efient 10 mg, Plavix 75 mg, Brilique 90 mg, or Aspirine 100 mg. These are all taken orally as tablets.

The specific medication and dosage will depend on the group you are assigned to. You will take the medication as directed by the study team.

4 monitoring and testing

Throughout the study, your platelet activity will be monitored. This involves measuring how well your blood cells called platelets are working.

At 30 days after randomization, a test called VerifyNow will be used to measure platelet reactivity. This helps assess the effectiveness of the treatment.

5 follow-up assessments

You will have follow-up assessments at 6 months to check for any bleeding events or other health issues.

The study will also evaluate the occurrence of any major adverse events such as heart attacks or strokes during this period.

6 completion of the study

Once the study period is over, your participation will be complete. The study team will provide you with any necessary information about your health and the results of the study.

Your contribution will help in understanding the effectiveness of individualized treatment strategies for patients with coronary artery disease.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must have Chronic Coronary Syndrome (CCS) and be undergoing a successful elective percutaneous coronary intervention (PCI). This is a procedure to open up blood vessels in the heart.
Patients must provide written informed consent, which means they agree to participate in the study after being informed about it, as approved by the ethics committee.

Who Cannot Join the Study?

Patients with any condition that makes it unsafe to participate in the study.
Patients who are unable to follow the study procedures.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions to the study medication.
Patients currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients with unstable medical conditions that require immediate treatment.
Patients who have had a heart attack or stroke in the last 6 months.
Patients with severe liver or kidney disease.
Patients with a history of bleeding disorders.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

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

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	06.11.2023

Trial locations

Investigated drugs:

P2Y12-inhibitor monotherapy is a treatment that focuses on using a single medication to prevent blood cells called platelets from clumping together. This is important for patients with coronary artery disease who are undergoing a procedure to open up their heart arteries. The therapy is guided by a genetic test to see how well your body can process the medication, which helps in choosing the right drug for you. The goal is to reduce the risk of blood clots and improve blood flow to the heart.

Standard DAPT stands for Dual Antiplatelet Therapy, which is a common treatment for patients with heart artery problems. It involves taking two medications that work together to prevent platelets from sticking together and forming clots. This therapy is typically used after procedures to open up blocked heart arteries, helping to keep the arteries open and reduce the risk of heart attacks or other complications.

Investigated diseases:

Stable Coronary Artery Disease – This condition involves the narrowing or blockage of the coronary arteries, which supply blood to the heart muscle. It is characterized by chest pain or discomfort, known as angina, which typically occurs with physical exertion or stress and is relieved by rest or medication. The disease progresses as the arteries become more narrowed due to the buildup of fatty deposits, known as plaques. Over time, this can lead to reduced blood flow to the heart, causing symptoms to become more frequent or severe. The condition can remain stable for years, but it may also progress to more serious heart problems if not managed properly.

Chronic Coronary Syndrome – This syndrome refers to a group of conditions that result from long-term, reduced blood flow to the heart muscle due to coronary artery disease. It is marked by episodes of chest pain or discomfort, often triggered by physical activity or emotional stress, and relieved by rest. The progression involves the gradual buildup of plaques in the coronary arteries, leading to a persistent reduction in blood supply to the heart. As the disease advances, the heart may struggle to receive enough oxygen, especially during increased activity. This can lead to more frequent or severe symptoms and may eventually affect heart function. The condition requires ongoing management to prevent further complications.

Trial ID:

2023-504078-39-01

Protocol code:

2023-504078-39-01

NCT ID:

NCT05773989

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Personalized Anti-Platelet Therapy with Prasugrel, Clopidogrel, and Ticagrelor for Patients with Stable Coronary Artery Disease Undergoing Stenting

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?