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

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What is this study about?

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.

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.

2 medication administration

Receive prasugrel 10 mg and acetylsalicylic acid 75 mg, both in film-coated tablet form.

Both medications are taken orally.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Aftcli Uceprjeqfu Hcydotyv	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	15.09.2024

Trial locations

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.

Investigated diseases:

Acute coronary syndrome

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.

Trial ID:

2024-515236-69-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?