Not recruiting

Study on Blood Thinners Apixaban, Edoxaban, Rivaroxaban, and Acetylsalicylic Acid for Patients with Aortic Stenosis After Heart Valve Replacement

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 patients with aortic stenosis, a condition where the heart's aortic valve narrows, affecting blood flow. The study aims to find the best blood-thinning treatment after patients undergo a procedure called transcatheter aortic valve implantation (TAVI), which involves placing a new valve in the heart without open-heart surgery. The treatments being studied include medications known as anticoagulants and acetylsalicylic acid, commonly known as aspirin. The anticoagulants being tested are apixaban, edoxaban, and rivaroxaban. These medications help prevent blood clots, which can be a concern after heart valve procedures.

The purpose of the study is to determine the most effective and safe treatment strategy for preventing complications such as blood clots and bleeding after TAVI. Participants in the study will be randomly assigned to receive either one of the anticoagulants or acetylsalicylic acid. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will last for up to 12 months, during which participants will take the assigned medication and attend regular follow-up visits to monitor their health and any side effects.

Throughout the study, researchers will closely observe the participants to assess the effectiveness of the treatments in preventing complications and improving overall health outcomes. The study will also evaluate the safety of these medications by monitoring for any adverse effects, such as bleeding or other health issues. The findings from this trial will help doctors make informed decisions about the best treatment options for patients with aortic stenosis who undergo TAVI.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, participants will be randomly assigned to receive one of the following medications: apixaban, edoxaban, rivaroxaban, or acetylsalicylic acid. These medications are taken orally, which means they are swallowed in the form of a pill or tablet.
Step 2
Medication administration
Participants will take the assigned medication as directed by the study team. The dosage and frequency will be specified by the healthcare provider overseeing the trial. It is important to follow the instructions carefully to ensure the effectiveness and safety of the treatment.
Step 3
Regular check-ups
Throughout the trial, participants will attend regular check-ups with the study team. These appointments are necessary to monitor health, assess the effects of the medication, and ensure that there are no adverse reactions.
Step 4
Monitoring and reporting
Participants are required to report any side effects or unusual symptoms to the study team immediately. This helps in assessing the safety and effectiveness of the medication.
Step 5
Completion of the trial
At the end of the trial period, participants will have a final evaluation. This includes a comprehensive health assessment to determine the overall impact of the medication on their condition.

Who can join the trial?

4 criteria

Age between 65 and 80 years old
Have had a successful TAVI procedure for aortic stenosis (TAVI stands for Transcatheter Aortic Valve Implantation, a procedure to replace a heart valve)
Have signed an informed consent form (a document that explains the study and confirms your agreement to participate)
Expected to follow the study protocol (able to follow the study's rules and instructions)

Who cannot join the trial?

10 criteria

Patients with a history of severe **bleeding disorders** (problems with blood clotting).
Patients who have had a recent **stroke** (a medical condition where poor blood flow to the brain results in cell death).
Patients with active **infections** (presence of harmful bacteria or viruses in the body).
Patients with severe **kidney disease** (when the kidneys are not working properly).
Patients with severe **liver disease** (when the liver is not functioning well).
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding.
Patients with known allergies to the study medication.
Patients with **uncontrolled high blood pressure** (when blood pressure is consistently too high).
Patients with severe **heart failure** (when the heart is not pumping blood as well as it should).

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Verified sites

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

Helse Bergen HF
Verified
Bergen, Norway
Oslo Universitetssykehus HF
Verified
Oslo, Norway

Trial locations

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Investigated drugs

AntiCoagulation
is a type of medication that helps prevent blood clots from forming. Blood clots can be dangerous because they can block blood vessels and lead to serious health problems like strokes or heart attacks. In this trial, the medication is being tested to see if it is effective in preventing blood clots in patients who have undergone a procedure called transcatheter aortic valve implantation, which is used to treat a condition known as aortic stenosis.
AcetylSalicylic Acid
, commonly known as aspirin, is a medication that is often used to relieve pain, reduce inflammation, and lower fever. It also has the ability to thin the blood, which can help prevent blood clots. In this trial, aspirin is being used to see if it can effectively prevent blood clots in patients who have had a transcatheter aortic valve implantation, similar to the role of the anticoagulation medication.

What is already known about the treatment

AntiCoagulation
This medication is administered orally and is used to prevent blood clots. It is currently being studied in clinical trials to determine its effectiveness compared to AcetylSalicylic Acid in patients who have undergone transcatheter aortic valve implantation for aortic stenosis. The main therapeutic indication is to reduce the risk of clot formation in the heart. At the molecular level, it works by inhibiting certain proteins in the blood that are necessary for clotting. It is classified as an anticoagulant.
AcetylSalicylic Acid
Commonly known as aspirin, this medication is taken orally and is used to relieve pain, reduce inflammation, and prevent blood clots. In the context of the clinical trial, it is being compared to AntiCoagulation to assess its effectiveness in patients with aortic stenosis who have undergone transcatheter aortic valve implantation. Its main therapeutic indication is to prevent clot formation. It works by inhibiting an enzyme involved in the production of molecules that promote inflammation and clotting. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and an antiplatelet agent.

Investigated diseases

Aortic stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed. This narrowing restricts blood flow from the heart to the rest of the body. Over time, the heart must work harder to pump blood through the narrowed valve, which can lead to thickening of the heart muscle. As the condition progresses, symptoms such as chest pain, fatigue, and shortness of breath may develop. In severe cases, it can lead to fainting or heart failure. The progression of aortic stenosis can vary, with some individuals experiencing rapid worsening of symptoms.