Not recruiting

Study on Short vs. 12-Month Use of Prasugrel and Aspirin for Patients with Acute Coronary Syndromes Undergoing Stent Procedures

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 clinical trial is focused on studying the treatment of acute coronary syndromes, which are conditions where the blood supply to the heart muscle is suddenly blocked. The study will use two medications: Hjertemagnyl, which contains acetylsalicylic acid (commonly known as aspirin), and Prasugrel Krka, which contains prasugrel. These medications are taken orally in the form of film-coated tablets. The purpose of the study is to compare the effects of a short-term treatment with these medications to a longer, 12-month treatment in patients who have been treated with a special type of heart stent called an everolimus-eluting stent.

Participants in the study will be randomly assigned to receive either the short-term or the 12-month treatment. The study will monitor for any bleeding events and major heart or brain-related issues, such as heart attacks or strokes, during the treatment period. The goal is to determine if the shorter treatment is as safe and effective as the longer one. The study will also look at other factors, such as the rate of stent-related problems and the overall quality of life of the participants.

This trial is expected to run until the end of 2028, with recruitment starting in September 2024. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the effectiveness of the treatment options being tested. The findings from this study could help improve treatment strategies for patients with acute coronary syndromes in the future.

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
Joining the study
Participation begins after meeting the criteria: being 18 years or older, having acute coronary syndromes, and being treated with an everolimus-eluting stent.
Eligibility requires the ability to be treated with prasugrel for 12 months.
Step 2
Medication administration
Receive prasugrel 10 mg and acetylsalicylic acid 75 mg, both in film-coated tablet form.
Both medications are taken orally.
Step 3
Treatment duration
The trial compares short-term antiplatelet therapy to a 12-month duration.
The focus is on patients treated with an everolimus-eluting stent.
Step 4
Evaluation period
Primary evaluation occurs between 1 and 12 months after the procedure.
Effectiveness is measured by clinically relevant bleeding and safety by major adverse cardiovascular or cerebrovascular events.
Step 5
Secondary assessments
Secondary assessments include individual components of the primary endpoint, stent thrombosis rate, major bleeding, health-related quality of life, and angina status.
Step 6
Trial duration
The trial is expected to conclude by December 31, 2028.
Recruitment is estimated to start on September 15, 2024.

Who can join the trial?

6 criteria

Patients must be **18 years or older**.
Patients must have **acute coronary syndromes**, which are conditions where the blood supply to the heart is suddenly blocked.
Patients must be treated with an **everolimus-eluting stent**, a small tube placed in the heart's blood vessels to keep them open.
Patients must be able to be treated with **prasugrel**, a medication that prevents blood clots, for **12 months**.
Both **men and women** can participate.
Participants should not belong to a **vulnerable population**, meaning they should not be in a group that needs special protection in research.

Who cannot join the trial?

3 criteria

Patients who have a condition other than acute coronary syndromes cannot participate. Acute coronary syndromes refer to a range of heart problems that happen when blood flow to the heart is suddenly reduced.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection, like children or people with certain disabilities.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Aarhus University Hospital
Verified
Aarhus, Denmark
Odense University Hospital
Verified
Odense, Denmark

Trial locations

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Investigated drugs

Prasugrel
is a medication used to prevent blood clots in people who have had a heart attack or severe chest pain and are undergoing a procedure to open blocked arteries. It works by stopping platelets in your blood from sticking together and forming clots.
Aspirin
is a common medication used to reduce pain, fever, or inflammation. In this trial, it is used in combination with prasugrel to prevent blood clots in patients with acute coronary syndromes who have been treated with a stent.
Everolimus-eluting stents
are small tubes placed in the coronary arteries to keep them open in patients with heart disease. These stents slowly release a medication called everolimus, which helps prevent the artery from becoming blocked again.

What is already known about the treatment

Prasugrel – Prasugrel is administered orally in tablet form and is used in combination with aspirin. It is currently recognized in medical literature as an effective antiplatelet medication, particularly in the context of acute coronary syndromes. The main therapeutic indication for prasugrel is to prevent blood clots in patients undergoing percutaneous coronary intervention, especially those treated with everolimus-eluting stents. At the molecular level, prasugrel works by inhibiting platelet activation and aggregation through the irreversible binding to the P2Y12 receptor on platelets. It is classified pharmacologically as a thienopyridine antiplatelet agent.

Investigated diseases

Acute Coronary Syndromes – Acute coronary syndromes refer to a range of conditions associated with sudden, reduced blood flow to the heart. This can include heart attacks and unstable angina, where the heart muscle doesn't receive enough oxygen-rich blood. Symptoms often include chest pain or discomfort, which may spread to the shoulders, arms, neck, or jaw. The condition can progress rapidly, leading to significant heart damage if not addressed promptly. It is often caused by the rupture of a plaque in a coronary artery, leading to a blockage. The severity and progression can vary, requiring immediate medical attention to prevent further complications.