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Reduced Dose Prasugrel Monotherapy After Stent Placement in Patients with Acute and Chronic Coronary Syndrome

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the use of a reduced dose of prasugrel (5 mg) as a single antiplatelet medication after a procedure called percutaneous coronary intervention (a minimally invasive procedure to open blocked or narrowed coronary arteries). The research focuses on patients with acute coronary syndrome (a range of conditions involving sudden reduced blood flow to the heart) and chronic coronary syndrome (long-term coronary artery disease with stable symptoms).

The purpose of the study is to evaluate whether using a lower dose of prasugrel alone is both feasible and safe for these patients after their procedure. Participants in the study will receive the reduced dose of prasugrel as their only antiplatelet medication, which helps prevent blood clots from forming in the arteries.

Throughout the study, researchers will monitor patients for various health outcomes, including complications like bleeding events and heart-related issues. They will also assess how satisfied patients are with the treatment and how well they adhere to the medication regimen.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the study
After your percutaneous coronary intervention (a procedure where a stent is placed in your heart arteries to keep them open), you will begin taking prasugrel 5 mg once daily.
This is a reduced dose of the medication compared to standard treatment, and you will take it as a single antiplatelet therapy (meaning you will not be taking aspirin or other blood thinning medications along with it).
The study will follow you for 12 months to assess how well this treatment approach works.
Step 2
Week 2 assessment
If you are among the first 40 patients in the study, you will have a blood test at week 2 to check your platelet reactivity (how well your blood clotting cells are responding to the medication).
Step 3
Follow-up visits
You will have follow-up assessments at 1 month, 6 months, and 12 months after starting the treatment.
During these visits, the medical team will check for any signs of bleeding, heart problems, or other health issues.
They will also monitor if you've had any complications related to your stent or if you've needed any additional heart procedures.
Step 4
Questionnaires
During the study, you will complete two questionnaires:
The Treatment Satisfaction Questionnaire for Medication II (TSQM-II) to assess how satisfied you are with the medication.
The Morisky Medication Adherence Scale (MMAS-8) to evaluate how well you're able to take the medication as prescribed.
Step 5
Monitoring for side effects
Throughout the study period, the medical team will monitor you for any bleeding events, which are classified according to severity.
They will also track any heart-related events such as heart attacks, stent blockages, or strokes.
Any other health issues will be documented to assess the overall safety of this treatment approach.
Step 6
Completion of study
The study will conclude after your 12-month assessment, or earlier if determined by your doctor.
After completing the study, your doctor will advise you on continuing appropriate medication for your heart condition.

Who can join the trial?

4 criteria

You must have a heart condition called acute coronary syndrome (sudden blockage in the heart arteries causing chest pain or heart attack) or chronic coronary syndrome (long-term heart disease with stable symptoms).
You must have undergone a percutaneous coronary intervention (PCI), which is a non-surgical procedure where a stent is placed in your blocked heart arteries to restore blood flow.
Your PCI procedure must have been successful, as determined by your doctor.
You must be able to take the blood-thinning medication prasugrel at a reduced dose of 5 mg.

Who cannot join the trial?

12 criteria

You cannot participate if you are younger than 18 years old.
You cannot participate if you have a known allergy or sensitivity to prasugrel (a medication used to prevent blood clots).
You cannot participate if you have a history of stroke or mini-stroke (also called transient ischemic attack or TIA).
You cannot participate if you have active bleeding (ongoing loss of blood).
You cannot participate if you have a high risk of bleeding, including a history of bleeding disorders.
You cannot participate if you have severe liver disease.
You cannot participate if you are currently taking anticoagulant medications (blood thinners like warfarin).
You cannot participate if you have had another heart procedure within the last 30 days.
You cannot participate if you are pregnant or breastfeeding.
You cannot participate if you have a life expectancy of less than 12 months.
You cannot participate if you are already enrolled in another clinical trial.
You cannot participate if you are unable to provide informed consent.

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Prasugrel is a medication that helps prevent blood clots. It belongs to a class of drugs called antiplatelet agents, which work by stopping platelets (a type of blood cell) from sticking together and forming clots. In this trial, a reduced dose of 5 mg is being studied as a single antiplatelet therapy for patients who have undergone a procedure called percutaneous coronary intervention (a non-surgical procedure that uses a catheter to place a stent to open blocked coronary arteries).

Prasugrel

What is already known about the treatment

Prasugrel - An oral antiplatelet medication typically administered as a tablet that works by preventing blood platelets from sticking together to form clots. Prasugrel is approved for use in patients with acute coronary syndrome (including heart attacks) who are undergoing percutaneous coronary intervention (stent placement), where it helps reduce the risk of future cardiovascular events by blocking the P2Y12 receptor on platelets, thereby inhibiting platelet activation and aggregation. It belongs to the class of thienopyridine antiplatelet agents and is often prescribed alongside aspirin as dual antiplatelet therapy, though this clinical trial is specifically investigating its use as a single therapy at a reduced dose (5 mg) after stent placement.

Investigated diseases

Acute Coronary Syndrome
A term that covers a range of conditions where blood supply to the heart muscle is suddenly blocked or reduced. It is characterized by the rupture of an atherosclerotic plaque in a coronary artery, leading to the formation of a blood clot. This results in reduced blood flow to part of the heart muscle, causing oxygen deprivation. Symptoms typically include chest pain, shortness of breath, and anxiety. Acute coronary syndrome encompasses unstable angina and different types of myocardial infarction (heart attack).
Chronic Coronary Syndrome
A persistent condition involving the buildup of plaque in the coronary arteries, which gradually narrows the vessels supplying blood to the heart. This process, known as atherosclerosis, develops over many years and can be stable for long periods. As the disease progresses, the heart muscle may receive insufficient oxygen during periods of increased demand, such as during physical activity. This can lead to recurring chest pain (stable angina) that typically resolves with rest. Unlike acute coronary syndrome, chronic coronary syndrome represents a more stable, long-term disease state.