Study on Reducing Antiplatelet Therapy in Patients with Acute Coronary Syndrome and High Bleeding Risk Using Prasugrel, Ticagrelor, or Clopidogrel

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What is this study about?

This clinical trial is focused on studying the effects of different medications on patients who have experienced an Acute Coronary Syndrome (ACS), a condition where the blood supply to the heart is suddenly blocked. The study involves patients who have had a stent placed in their coronary arteries and are at a high risk of bleeding. The medications being tested include Ticagrelor, Acetylsalicylic Acid (commonly known as aspirin), Clopidogrel, and Prasugrel. These medications are known as antiplatelet drugs, which help prevent blood clots by stopping platelets, a type of blood cell, from sticking together.

The purpose of the study is to evaluate how different doses of these antiplatelet drugs affect platelet reactivity, which is how well the platelets respond to the medication. The study will compare lower doses of Prasugrel (5 mg), Ticagrelor (60 mg twice daily), and Clopidogrel (75 mg) with the full doses of Prasugrel (10 mg) and Ticagrelor (90 mg twice daily). The goal is to find out which treatment helps achieve the best balance in platelet activity, known as optimal platelet reactivity, without causing excessive bleeding.

Participants in the study will take the medications for a period of up to six months. During this time, their platelet reactivity will be monitored to see how the medications are working. The study will also track any bleeding events and other health outcomes, such as heart attacks or strokes, to understand the overall safety and effectiveness of the treatment regimens. This research aims to improve treatment strategies for patients with Acute Coronary Syndrome who are at high risk of bleeding, ensuring they receive the most effective and safe care possible.

1 initial treatment phase

Upon joining the study, the patient receives treatment with full-dose potent P2Y12 inhibitors. These include prasugrel at 10 mg or ticagrelor at 90 mg, taken twice daily. This phase is in accordance with international guidelines for patients who have recently experienced an acute coronary syndrome and undergone stent implantation.

2 randomization and treatment adjustment

After the initial treatment phase, the patient is randomly assigned to one of three different treatment regimens. These regimens involve a reduction in the dosage of P2Y12 inhibitors to evaluate their effect on platelet reactivity.

The options include prasugrel at 5 mg, ticagrelor at 60 mg taken twice daily, or clopidogrel at 75 mg. The goal is to determine which treatment achieves the optimal platelet reactivity at a steady state.

3 monitoring and assessment

The primary endpoint is assessed 14±2 days after study inclusion. The patient’s platelet reactivity is measured using the VerifyNow system, which provides a platelet reactivity unit (PRU) score. The optimal range is defined as a PRU between 85 and 208.

Secondary endpoints include the incidence of bleeding events, categorized as nuisance, minor, or major, and other clinical events such as death, myocardial infarction, or stroke. These are monitored throughout the study and up to 5 months after randomization.

4 follow-up and final evaluation

The study includes follow-up visits to assess adverse clinical events and other health outcomes. These visits occur at regular intervals up to 5 months after the initial randomization.

Additional assessments may include health mobility and mental scales, perceived stress, and adherence to the treatment regimen.

Who Can Join the Study?

The patient must have signed and dated an Informed Consent, which is a document that explains the study and confirms the patient’s agreement to participate.
The patient must be considered at HBR (High Bleeding Risk) based on standard definitions, such as having a PRECISE-DAPT score of 25 or more, or meeting the HBR-ARC criteria with at least one major or two minor conditions.
The patient must have been treated with PCI (Percutaneous Coronary Intervention), a procedure to open blocked heart arteries, due to a recent ACS (Acute Coronary Syndrome), which includes conditions like unstable angina or heart attacks, within the last 30 days, plus or minus 7 days.
The patient must have been treated with DAPT (Dual Antiplatelet Therapy) using full-dose potent P2Y12 inhibitors like prasugrel 10mg or ticagrelor 90mg twice a day, following international guidelines.
Both male and female patients are eligible to participate.
The study does not include vulnerable populations, which means it focuses on individuals who are not considered at additional risk due to their circumstances.

Who Cannot Join the Study?

Patients with a history of acute coronary syndrome cannot participate. This is a condition where the blood supply to the heart is suddenly blocked.
Patients who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Patients who are part of a vulnerable population are not eligible. This means people who might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Aqxennw Sswdkdyyt Lsfdnj Tlb	Rivoli	Italy
Mhxsz Ctftwyj Hdxuamkz Smoyin	Cotignola	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	24.06.2023

Trial locations

Investigated drugs:

Prasugrel is a medication used to prevent blood clots in patients who have had a recent heart attack or have undergone procedures like coronary stenting. It works by making the blood less sticky, which helps to reduce the risk of future heart-related problems.

Ticagrelor is another medication that helps prevent blood clots in patients with heart conditions. It is often used after a heart attack or stenting procedure to keep the blood flowing smoothly and reduce the risk of further heart issues.

Clopidogrel is a medication that helps prevent blood clots by stopping platelets in the blood from sticking together. It is commonly used in patients who have had a heart attack or have undergone procedures like coronary stenting to prevent future heart problems.

Investigated diseases:

Acute coronary syndrome

Acute Coronary Syndrome – Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It often results from the buildup of fatty deposits in and on the walls of coronary arteries, which can rupture and form a clot. This can lead to chest pain or discomfort, often described as a feeling of pressure or tightness in the chest. The condition can also cause shortness of breath, nausea, or lightheadedness. It is a critical condition that requires immediate medical attention to restore blood flow and prevent heart damage. The progression of the disease can vary, but it often involves episodes of chest pain and may lead to more severe heart problems if not managed properly.

Trial ID:

2023-509868-20-00

Protocol code:

DESC-HBR

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing Antiplatelet Therapy in Patients with Acute Coronary Syndrome and High Bleeding Risk Using Prasugrel, Ticagrelor, or Clopidogrel

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?