Study on Ticagrelor and Clopidogrel for Patients with Coronary Artery Disease Undergoing PCI

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What is this study about?

This clinical trial is focused on patients with coronary artery disease who need a procedure called percutaneous coronary intervention (PCI). The study is examining two medications: Brilique (also known as ticagrelor) and Clopidogrel Medreg (also known as clopidogrel). These medications are used to prevent blood clots, which can help reduce the risk of heart attacks and strokes. The purpose of the study is to see if using genetic testing to choose between these medications can be safe and effective for patients who are also taking blood thinners known as direct oral anticoagulants (DOACs).

Participants in the study will be randomly assigned to receive either Brilique or Clopidogrel Medreg. The study will last for about 12 months, during which time the safety and effectiveness of the medication will be monitored. This includes checking for any major bleeding events and tracking any occurrences of heart attacks, strokes, or issues with the stent used in PCI. The study will also use a health questionnaire to assess the overall well-being of participants.

The study aims to provide valuable information on whether genetic testing can help tailor the choice of medication for patients undergoing PCI, potentially improving outcomes and reducing risks. This approach could lead to more personalized treatment plans for individuals with coronary artery disease who are also on DOACs.

1 joining the study

Participation begins after providing written informed consent, as approved by the ethics committee.

Eligibility includes being 18 years or older, having coronary artery disease, and undergoing a procedure called PCI (percutaneous coronary intervention).

2 genetic testing

A genetic test is conducted to determine the CYP2C19 genotype. This helps in selecting the appropriate medication for managing blood clots.

3 medication administration

Based on genetic test results, one of two medications is prescribed: ticagrelor or clopidogrel.

Ticagrelor is taken as a 90 mg film-coated tablet, administered orally.

Clopidogrel is taken as a 75 mg film-coated tablet, administered orally.

The medication is taken as part of the treatment plan for patients who require ongoing anticoagulation therapy.

4 follow-up and monitoring

The study monitors safety and effectiveness over a 12-month period.

Primary safety concerns include major and non-major bleeding events.

Primary effectiveness measures include rates of death, heart attack, stroke, and issues with the stent.

5 completion of study

The study concludes with an evaluation of outcomes, comparing results to established performance goals.

Participants may be asked to complete a health survey called the EQ5D5L, which assesses health across five dimensions.

Who Can Join the Study?

Patients must be 18 years of age or older.
Patients must have a need for indefinite (D)OAC. This means they need to take a certain type of blood-thinning medication for an indefinite period.
Patients must be undergoing a successful PCI. PCI stands for Percutaneous Coronary Intervention, a procedure to open up blood vessels in the heart.
Patients must have stable or unstable coronary artery disease. This refers to a condition where the blood vessels in the heart are narrowed or blocked.
Patients must provide written informed consent. This means they agree to participate in the study after being informed about it, and this consent is approved by an ethics committee.

Who Cannot Join the Study?

Patients who do not have coronary artery disease.
Patients who do not need a procedure called PCI, which is a treatment to open up blood vessels in the heart.
Patients who are not indicated for (D)OAC, which are medications that help prevent blood clots.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Ehfvivb Uhlfwqkozibq Mtapveg Cuthdrm Rsxsmazaz (sunjter Mdg	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	19.04.2023

Trial locations

Investigated drugs:

Clopidogrel is a medication used to prevent blood clots in patients who have had a heart attack, stroke, or other conditions related to heart and blood vessels. In this study, it is used to see how genetic testing can help choose the right antithrombotic treatment for patients undergoing a procedure called PCI (Percutaneous Coronary Intervention).

CYP2C19-genotype-guided p2y12 inhibitor selection is a method used in this study to tailor the choice of antithrombotic medication based on a patient’s genetic makeup. This approach aims to improve the safety and effectiveness of the treatment by selecting the most suitable medication for each individual.

Investigated diseases:

Coronary artery disease

Coronary Artery Disease – This condition involves the narrowing or blockage of the coronary arteries, usually due to atherosclerosis, which is the buildup of cholesterol and fatty deposits on the artery walls. As the arteries narrow, blood flow to the heart muscle can be reduced, leading to chest pain or discomfort known as angina. If a coronary artery becomes completely blocked, it can result in a heart attack. Over time, coronary artery disease can weaken the heart muscle and contribute to heart failure or arrhythmias. The progression of the disease can vary, with some individuals experiencing rapid worsening of symptoms, while others may have a more gradual progression.

Trial ID:

2024-512350-17-01

Protocol code:

NL77315.078.21

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ticagrelor and Clopidogrel for Patients with Coronary Artery Disease Undergoing PCI

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?