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Study on Short vs. Long Antiplatelet Therapy with Aspirin for Adults After TAVI for Symptomatic Aortic Stenosis

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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 who have undergone a procedure called transcatheter aortic valve implantation (TAVI) to treat a condition known as aortic stenosis. Aortic stenosis is a narrowing of the heart's aortic valve, which can lead to symptoms like chest pain, fatigue, and shortness of breath. The study is comparing two different durations of treatment with aspirin, a common medication used to prevent blood clots. The two forms of aspirin being studied are KARDEGIC 75 mg, which is a powder for oral solution, and ASPIRINE PROTECT 100 mg, which is a gastro-resistant tablet. Both medications are taken by mouth.

The purpose of the study is to determine if a shorter duration of aspirin therapy, lasting 3 months, is as effective as the standard 12-month therapy in preventing certain health events after the TAVI procedure. These health events include things like heart attacks, strokes, and significant bleeding. Participants in the study will be randomly assigned to either the short-term or long-term aspirin therapy group. The study will follow participants for 12 months to monitor their health and any events that occur.

Throughout the study, participants will receive regular check-ups to assess their health and any side effects from the treatment. The study aims to provide valuable information on the optimal duration of aspirin therapy for patients who have undergone TAVI, potentially improving treatment guidelines and patient outcomes in the future.

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 study
Upon joining the study, participation begins after a successful transfemoral trans-aortic valve implantation (TAVI) for symptomatic aortic stenosis. This procedure involves placing a new heart valve through a blood vessel in the leg.
Eligibility includes being 18 years or older, having a successful TAVI, and providing written informed consent.
Step 2
Randomization
Participants are randomly assigned to one of two groups: the experimental group or the standard group.
The experimental group receives aspirin therapy for 3 months, while the standard group receives aspirin therapy for 12 months.
Step 3
Medication administration
Participants take aspirin orally, with a dosage ranging from 75 mg to 100 mg daily.
The medication is available in two forms: an oral solution (KARDEGIC 75 mg) and a gastro-resistant tablet (ASPIRINE PROTECT 100 mg).
Step 4
Follow-up period
The follow-up period lasts for 12 months after the TAVI procedure.
During this time, the study evaluates the net clinical benefit, which includes monitoring for any major health events such as death, heart attack, or significant bleeding.
Step 5
Evaluation and outcomes
The primary outcome is assessed by comparing the occurrence of major health events between the two groups over the 12-month period.
Secondary outcomes include evaluating any bleeding events, cardiovascular events, and overall quality of life using specific health scales.

Who can join the trial?

9 criteria

Must be **18 years or older**.
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Must have had a **successful transfemoral TAVI** for **symptomatic aortic stenosis**. This means:
- Successful access and delivery of the device, and retrieval of the delivery system.
- Correct positioning of a single prosthetic heart valve in the right place.
- No need for surgery or intervention related to the device, except for a permanent pacemaker, or due to major complications related to blood vessels, access, or heart structure.
- Must provide **written informed consent**. This means agreeing to participate after understanding the study.
- Must be **affiliated with social security**.
- Must be **French speaking**.
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  Must be **male** or a **female** who is either:
  - Post-menopausal, meaning no menstrual periods for 12 months without another medical reason.
  - Permanently sterilized, which includes procedures like hysterectomy (removal of the uterus), bilateral salpingectomy (removal of both fallopian tubes), or bilateral oophorectomy (removal of both ovaries).

Who cannot join the trial?

2 criteria

Patients who have not had a successful **transfemoral trans-aortic valve implantation (TAVI)**. This is a procedure to replace a heart valve through a blood vessel in the leg.
Patients with other medical reasons that require long-term use of **antiplatelet** or **anticoagulant** therapy. These are medications that help prevent blood clots.

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Verified sites

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CHU Grenoble Alpes
La Tronche, France
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Centre Hospitalier Regional D'Angers
Angers, France
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Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France

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Investigated drugs

Aspirin is a medication used in this trial to prevent blood clots. It is an antiplatelet drug, which means it helps stop platelets in your blood from sticking together and forming clots. In this study, aspirin is being tested in two different treatment durations to see if a shorter treatment period is as effective as a longer one in preventing certain clinical events after a heart procedure called TAVI.

What is already known about the treatment

Aspirin – Aspirin is administered orally in tablet form, typically in doses ranging from 75 to 100 mg. It is widely recognized in medical literature as a common antiplatelet medication used to reduce the risk of blood clots. The main therapeutic indication for aspirin in this context is to manage patients who have undergone transfemoral trans-aortic valve implantation (TAVI) for symptomatic aortic stenosis, without other needs for long-term antiplatelet or anticoagulant therapy. At the molecular level, aspirin works by inhibiting the enzyme cyclooxygenase, which in turn reduces the production of thromboxane, a molecule that promotes platelet aggregation. It is classified pharmacologically as a non-steroidal anti-inflammatory drug (NSAID) with antiplatelet properties.

Investigated diseases

Aortic Stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed, restricting blood flow from the heart to the rest of the body. Over time, this narrowing can lead to increased pressure within the heart, causing the heart muscle to thicken and potentially weaken. Symptoms may include chest pain, fatigue, shortness of breath, and fainting, especially during physical activity. As the condition progresses, the heart may struggle to pump blood effectively, leading to heart failure. The progression of aortic stenosis can vary, with some individuals experiencing rapid worsening of symptoms, while others may have a more gradual decline. Regular monitoring and medical evaluation are essential to manage the condition effectively.