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Study on Clopidogrel and Acetylsalicylic Acid for Patients with Coronary Artery Disease and Non-ST-segment Elevation Acute Coronary Syndrome

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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 effects of a medication called Clopidogrel on patients with Coronary Artery Disease and a specific type of heart condition known as Non-ST-segment Elevation Acute Coronary Syndrome (NSTE-ACS). The study will explore how well Clopidogrel works when used alone, guided by a genetic test, in patients who have undergone a procedure called percutaneous coronary intervention (PCI), which involves placing a small tube in the heart's blood vessels to keep them open.

The purpose of the study is to assess both the risk of heart-related problems and the risk of bleeding when using Clopidogrel in this way. Participants will be monitored for six months after their PCI procedure. During this time, researchers will look at the occurrence of events such as heart attacks, strokes, and any bleeding issues. The study will also compare these outcomes to those of patients who might receive other treatments, including a placebo.

Throughout the study, participants will take Clopidogrel in the form of film-coated tablets. Another medication, Acetylsalicylic Acid, commonly known as aspirin, may also be used in some cases. The study aims to provide valuable information on the safety and effectiveness of Clopidogrel for patients with these heart conditions, helping to guide future treatment decisions.

The research process

The trial runs in 4 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, eligibility is confirmed based on criteria such as being 18 years or older, having a clinical diagnosis of non-ST-segment elevation acute coronary syndrome (NSTE-ACS), and having undergone a successful percutaneous coronary intervention (PCI) with drug-eluting stents.
A genetic test is conducted to determine if the patient is a CYP2C19 extensive or ultra-rapid metabolizer, which is necessary for participation.
Step 2
Medication administration
The trial involves taking two medications: acetylsalicylic acid and clopidogrel. Both are taken orally.
Acetylsalicylic acid is administered as a dispersible tablet with a dosage of 80 mg.
Clopidogrel is administered as a film-coated tablet with a dosage of 75 mg.
The medications are taken daily for a duration of 6 months.
Step 3
Monitoring and follow-up
Throughout the 6-month period, the trial assesses the risk of ischemic events, such as heart attacks or strokes, and the risk of bleeding.
Primary endpoints are evaluated at 3 and 6 months, including all-cause mortality, myocardial infarction, stent thrombosis, ischemic stroke, and major or minor bleeding.
Secondary endpoints include cardiovascular and non-cardiovascular mortality, any need for revascularization, and any procedural complications.
Step 4
Completion of the trial
At the end of the 6-month period, a final assessment is conducted to evaluate the overall efficacy and safety of the genotype-guided clopidogrel monotherapy.
The trial is estimated to conclude by July 26, 2026.

Who can join the trial?

4 criteria

Must be 18 years or older.
Must have a clinical diagnosis of Non-ST-segment Elevation Acute Coronary Syndrome (NSTE-ACS), which includes conditions like NSTEMI (a type of heart attack) or unstable angina (a condition where the heart doesn't get enough blood flow and oxygen).
Must have had a successful PCI (a procedure to open up blood vessels in the heart) with the placement of new generation drug-eluting stents (special tubes that release medication to keep the blood vessel open), as determined by the treating doctor.
Must be a CYP2C19 extensive or ultra-rapid metabolizer, which means your body processes certain medications in a specific way based on your genetic makeup.

Who cannot join the trial?

5 criteria

Patients with a history of **Coronary Artery Disease** cannot participate.
Patients with **Non-ST-segment Elevation Acute Coronary Syndrome** are excluded.
Patients who have not undergone a successful **PCI** (a procedure to open blocked blood vessels in the heart) are not eligible.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population are not eligible.

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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 people who have had a heart attack, stroke, or other heart-related issues. In this clinical trial, it is being used as a single therapy to see if it can effectively reduce the risk of heart problems and bleeding in patients who have undergone a procedure to open blocked heart arteries. The trial is also looking at how a person's genetic makeup might affect how well the medication works for them.

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 people with coronary artery disease or those who have experienced a non-ST-segment elevation acute coronary syndrome. It is currently well-established in medical practice and literature as a standard treatment for reducing the risk of heart attacks and strokes. The main therapeutic use of clopidogrel is to prevent clot formation by inhibiting platelets, which are small blood cells that clump together to form clots. At the molecular level, clopidogrel works by blocking a specific receptor on the platelets, preventing them from sticking together. It is classified as an antiplatelet drug, which means it helps keep blood flowing smoothly in the arteries.

Investigated diseases

Coronary Artery Disease
This disease 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 is reduced, which can lead to chest pain, known as angina. Over time, the reduced blood flow can cause damage to the heart muscle, potentially leading to heart attacks. The progression of the disease can be gradual, with symptoms worsening as the arteries become more blocked. It can also lead to complications such as heart failure or arrhythmias if not managed properly.
Non-ST-segment Elevation Acute Coronary Syndrome
This condition is a type of acute coronary syndrome that occurs when there is a partial blockage of the coronary arteries. It is characterized by chest pain or discomfort that may occur at rest or with minimal exertion. Unlike ST-segment elevation myocardial infarction, it does not show the classic ST-segment elevation on an electrocardiogram. The condition can lead to damage to the heart muscle due to reduced blood flow, but the extent of damage is typically less severe than with a complete blockage. Over time, if the blockage worsens, it can progress to a more severe form of heart attack.