Not recruiting

Study on Aspirin and Pantoprazole for Reducing Heart Attack Risk in Hospitalized Pneumonia Patients

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 effects of adding a medication called aspirin to the usual treatment for patients with pneumonia. Pneumonia is an infection that inflames the air sacs in one or both lungs, which can fill with fluid. The study aims to see if taking aspirin can help reduce the risk of heart problems, specifically acute coronary syndrome, which includes conditions like heart attacks, in patients who are hospitalized with pneumonia.

Participants in the study will receive either aspirin or a placebo, which looks like the aspirin tablet but does not contain any active medication. The study will also involve another medication called pantoprazole, which is used to protect the stomach lining. The treatment period will last for up to 90 days, and the researchers will monitor the participants' health for any heart-related events and other outcomes over a period of 180 days.

The goal of this study is to determine if aspirin can provide additional benefits in preventing heart-related complications in patients with pneumonia. By understanding the potential benefits of aspirin in this context, the study hopes to improve treatment strategies for patients with pneumonia who are at risk of heart problems. Participants will be closely monitored throughout the study to ensure their safety and well-being.

The research process

The trial runs in 4 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 specific criteria: being 40 years or older, having community-acquired pneumonia with clinical and radiological evidence, a CURB-65 score of 2 or higher, or a PSI score of 3 or higher, and being admitted to the hospital.
Step 2
Medication administration
Receive a daily oral dose of acetylsalicylic acid (Aspirin) 80 mg in the form of a gastro-resistant tablet. This medication is intended to prevent cardiovascular events.
Receive a daily oral dose of pantoprazole 20 mg in the form of a gastro-resistant tablet to protect the stomach lining.
A placebo may also be administered orally in the form of a dispersible tablet.
Step 3
Monitoring and follow-up
The primary goal is to observe the incidence of acute coronary syndrome up to day 180.
Secondary observations include the incidence of major cardiovascular events, bleeding complications, length of hospital stay, and mortality at day 90 and day 180.
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, and societal costs will be measured with IMCQ and IPCQ up to day 180.
Step 4
Completion of the study
The study is expected to conclude by April 1, 2028, with ongoing assessments and data collection throughout the trial period.

Who can join the trial?

4 criteria

Must be 40 years or older.
Must have community-acquired pneumonia, which means pneumonia that was not acquired in a hospital. This is identified by symptoms of pneumonia and a chest X-ray showing a new lung infection.
Must have moderate to severe pneumonia. This is determined by a score of 2 or higher on the CURB-65 test or a score of 3 or higher on the PSI test. These tests help doctors understand how serious the pneumonia is.
Must be admitted to the hospital for treatment.

Who cannot join the trial?

2 criteria

Patients who have had a myocardial infarction, which is commonly known as a heart attack.
Patients who currently have pneumonia, which is an infection that inflames the air sacs in one or both lungs.

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Verified sites

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

Verified
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Diakonessenhuis Stichting
Utrecht, The Netherlands
Verified
Frisius
Heerenveen, The Netherlands

Trial locations

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Investigated drugs

Aspirin is being studied to see if it can help prevent heart problems in patients who have pneumonia. Researchers want to find out if taking aspirin along with antibiotics can lower the chances of having a heart attack or other heart issues while in the hospital.

What is already known about the treatment

Aspirin – Aspirin is typically administered orally in tablet form. It is widely recognized in medical literature as a common medication used to reduce pain, fever, and inflammation. In this clinical trial, it is being investigated for its potential to prevent cardiovascular events, such as myocardial infarction, in patients with community-acquired pneumonia. Aspirin works by inhibiting the enzyme cyclooxygenase, which reduces the production of substances that promote inflammation and blood clotting. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and an antiplatelet agent.

Investigated diseases

Myocardial Infarction
This condition, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. The blockage is usually caused by a buildup of fat, cholesterol, and other substances, which form a plaque in the arteries that supply the heart. Symptoms often include chest pain, shortness of breath, and discomfort in other areas of the upper body. The progression can lead to significant damage to the heart muscle if not addressed promptly. Over time, this can affect the heart's ability to pump blood effectively.
Pneumonia
This is an infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus, causing cough with phlegm or pus, fever, chills, and difficulty breathing. It can be caused by a variety of organisms, including bacteria, viruses, and fungi. The severity of pneumonia can range from mild to life-threatening, with the most severe cases often occurring in infants, young children, and older adults. As the disease progresses, it can lead to complications such as pleurisy, lung abscesses, or acute respiratory distress syndrome. The infection can spread to the bloodstream, causing sepsis, or to other parts of the body.