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

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What is this study about?

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.

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.

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.

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).

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.

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 Study?

  • Must be 18 years or older.
  • 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.
  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Clinique Pasteur Toulouse France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De La Reunion St Denis France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.01.2024

Trial locations

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.

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.

Trial ID:
2023-508208-40-00
Trial Phase:
Therapeutic use (Phase IV)

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