Study on Prasugrel or Ticagrelor for Patients with Atrial Fibrillation and Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

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What is this study about?

This clinical trial is focused on patients with atrial fibrillation and a type of heart attack known as acute coronary syndrome, which includes ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). These patients are undergoing a procedure called percutaneous coronary intervention (PCI), which helps to open blocked heart arteries. The study aims to explore whether using a stronger form of blood-thinning medication, specifically a P2Y12-inhibitor like Prasugrel or Ticagrelor, for a short period of four weeks can help reduce the risk of further heart-related issues without causing more bleeding problems.

Participants in the study will receive either Prasugrel or Ticagrelor, which are medications that help prevent blood clots by stopping platelets (a type of blood cell) from sticking together. These medications will be compared to other treatments, including Acetylsalicylic Acid (commonly known as aspirin) and Clopidogrel, which also work to prevent blood clots but in different ways. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients.

The study will last for several weeks, during which participants will take the assigned medication and be monitored for any heart-related events or bleeding issues. The goal is to determine if the stronger blood-thinning medications can effectively reduce the risk of heart problems without significantly increasing the risk of bleeding. The results of this study could help improve treatment strategies for patients with atrial fibrillation and acute coronary syndrome who undergo PCI.

1 joining the trial

Upon joining the trial, you will be required to provide written informed consent. This is a document that confirms your agreement to participate in the study after understanding all the details and potential risks involved.

You must be at least 18 years old and have a condition known as atrial fibrillation, which requires treatment with oral anticoagulation. Additionally, you should have experienced a heart condition called STEMI or NSTEMI, which are types of heart attacks.

2 randomization

After successfully undergoing a procedure called percutaneous coronary intervention (PCI), you will be randomly assigned to a treatment group within 5 days, preferably within 24 hours, before being discharged from the hospital.

3 medication administration

You will receive an escalated antiplatelet therapy with a potent P2Y12-inhibitor, which could be either prasugrel or ticagrelor. These medications are taken orally and are designed to prevent blood clots.

This treatment will last for 4 weeks. The goal is to reduce the risk of ischemic events, which are problems caused by reduced blood flow to the heart, without significantly increasing the risk of bleeding.

4 follow-up and monitoring

Throughout the trial, your health will be closely monitored. The primary focus will be on major ischemic events, such as heart attacks or strokes, and any bleeding complications.

The primary assessment will occur at 6 weeks after randomization, where the effectiveness and safety of the treatment will be evaluated.

5 end of trial assessments

At the end of the trial, which is estimated to conclude by June 30, 2026, additional assessments will be conducted to evaluate long-term outcomes, including all-cause mortality and any unplanned hospitalizations due to heart-related issues.

Who Can Join the Study?

Provide written informed consent, which means you agree to participate in the study after being informed about all aspects of it.
Be 18 years or older.
Have atrial fibrillation, a condition where the heart beats irregularly, and require treatment with blood-thinning medication.
Have experienced a heart attack, specifically either a STEMI or NSTEMI, which are types of heart attacks identified by specific tests.
Have successfully completed a PCI (Percutaneous Coronary Intervention), a procedure to open blocked heart arteries, with a blood flow grade of 2 or more. You must be randomized into the study within 5 days after this procedure, preferably within 24 hours, and before leaving the hospital.

Who Cannot Join the Study?

Patients who have a history of bleeding disorders. This means any condition that makes you bleed more easily than normal.
Patients with severe liver disease. The liver is an organ that helps process substances in your body, and severe disease can affect this process.
Patients who have had a stroke in the past. A stroke is when blood flow to a part of your brain is stopped or reduced, causing brain cells to die.
Patients with uncontrolled high blood pressure. This means your blood pressure is consistently higher than normal and not managed by medication or lifestyle changes.
Patients who are currently taking other medications that affect blood clotting. Blood clotting is the process that stops bleeding, and some medications can interfere with this process.
Patients with allergies to the study medications, such as Prasugrel or Ticagrelor. An allergy is when your body reacts negatively to a substance.
Patients who are pregnant or breastfeeding. Pregnancy and breastfeeding involve changes in the body that could affect the study results.
Patients who have any other serious medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Evangelisches Krankenhaus Hagen-Haspe gGmbH	Hagen	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Herzzentrum Leipzig GmbH	Leipzig	Germany
Barmherzige Brueder gemeinnuetzige Traeger GmbH	Straubing	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen	Munich	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Kerckhoff-Klinik GmbH	Bad Nauheim	Germany
Urvstnrxsgswbvumtmusg Enuqc Adv	Essen	Germany
Kjmefmyh Lylpzugut Eksmgc	Erding	Germany
Ufgusogcgtovbgfpwitlf Dvsghvkkgot Arn	Duesseldorf	Germany
Gnlzax Ujobfpeqkq Fuqfeteps	Frankfurt	Germany
Kyhpisvt dvl Uylawwjterhz Mnucppbu Aiq	Munich	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	22.12.2021
Germany	Not recruiting	22.12.2021

Trial locations

Investigated drugs:

Prasugrel is a medication that helps prevent blood clots. It works by stopping platelets, which are small blood cells, from sticking together. This is important for patients who have had a heart attack or other heart-related issues because it can help prevent further heart problems. In this trial, Prasugrel is used to see if it can reduce the risk of heart-related events without causing too much bleeding.

Ticagrelor is another medication that prevents blood clots by affecting platelets. Like Prasugrel, it is used to help people who have had heart attacks or similar conditions. The goal of using Ticagrelor in this study is to find out if it can lower the chances of having more heart issues while keeping the risk of bleeding low. This medication is part of the trial to see if it can be a safe and effective option for patients with specific heart conditions.

Investigated diseases:

Myocardial infarction

Atrial Fibrillation – Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) beat out of coordination with the lower chambers (ventricles). This can lead to poor blood flow and may cause symptoms such as heart palpitations, shortness of breath, and fatigue. Over time, atrial fibrillation can lead to complications like blood clots, which may increase the risk of stroke. The condition can be intermittent or persistent, with episodes that may last from minutes to hours or even longer. It often requires ongoing management to control the heart rate and rhythm.

ST-Segment Elevation Myocardial Infarction (STEMI) – STEMI is a type of heart attack that occurs when a coronary artery is completely blocked, leading to significant damage to the heart muscle. It is characterized by a specific pattern on an electrocardiogram (ECG) known as ST-segment elevation. This condition results in severe chest pain, which may radiate to other parts of the body, and is often accompanied by shortness of breath, sweating, and nausea. The blockage prevents oxygen-rich blood from reaching a portion of the heart, causing tissue death if not promptly treated. The progression of STEMI can lead to heart failure or other serious complications if the blood flow is not restored quickly.

Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) – NSTEMI is a type of heart attack that occurs when a coronary artery is partially blocked, reducing blood flow to the heart muscle. Unlike STEMI, NSTEMI does not show ST-segment elevation on an ECG, but it still results in damage to the heart tissue. Symptoms may include chest pain or discomfort, which can spread to the arms, neck, or jaw, along with shortness of breath and fatigue. The condition can lead to further heart complications if not managed properly. NSTEMI often requires careful monitoring and management to prevent further cardiac events.

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 includes conditions such as STEMI, NSTEMI, and unstable angina. Symptoms typically include chest pain or discomfort, which may be accompanied by nausea, sweating, and shortness of breath. The condition occurs when a plaque in a coronary artery ruptures or a blood clot forms, leading to a partial or complete blockage of the artery. This can result in damage to the heart muscle and requires immediate medical attention to restore blood flow and prevent further complications.

Trial ID:

2024-512727-36-00

Protocol code:

EPIDAURUS-2020

NCT ID:

NCT04981041

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Prasugrel or Ticagrelor for Patients with Atrial Fibrillation and Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

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