Study on Ticagrelor and Aspirin for Patients with Severe Aortic Stenosis After Heart Valve Replacement

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What is this study about?

This clinical trial is focused on studying the effects of two medications, Ticagrelor and Aspirin, in patients who have undergone a procedure called Transcatheter Aortic Valve Implantation (TAVI). The trial is specifically looking at patients with a condition known as Severe Symptomatic Aortic Stenosis, which is a narrowing of the heart’s aortic valve that can lead to serious heart problems. The purpose of the study is to assess the safety and effectiveness of these medications in preventing various health issues that might occur after the TAVI procedure.

Participants in the study will be randomly assigned to receive either Ticagrelor or Aspirin as a single antiplatelet treatment. Antiplatelet medications help prevent blood clots, which can be a concern after heart procedures. The study will monitor participants for 12 months to observe any significant health events, such as heart attacks, strokes, or bleeding. These events are collectively referred to as Net Adverse Clinical Events (NACE), which include all-cause mortality, transient ischemic attack (TIA) or stroke, myocardial infarction, progressive angina, valve thrombosis, claudication, acute limb ischemia, and any bleeding.

The trial aims to provide valuable information on which medication might be more beneficial for patients after TAVI. Participants will be closely monitored throughout the study period to ensure their safety and to gather data on the effectiveness of the treatments. The study will help determine the best approach to managing patients with severe aortic stenosis who have undergone TAVI, potentially improving outcomes and quality of life for these individuals.

1 joining the study

Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the details and purpose of the study.

You must be an adult over 18 years old and have been diagnosed with severe symptomatic aortic stenosis and accepted for a procedure called transcatheter aortic valve implantation (TAVI).

2 randomization

You will be randomly assigned to receive either ticagrelor or aspirin as a single antiplatelet treatment after your TAVI procedure.

This random assignment helps ensure the study results are unbiased and reliable.

3 medication administration

If assigned to ticagrelor, you will take Brilique 60 mg film-coated tablets orally.

If assigned to aspirin, you will take Adiro 100 mg gastro-resistant tablets orally.

The medication will be taken as directed by the study team, and you will continue this treatment for up to 12 months.

4 follow-up visits

You will have regular follow-up visits with the study team to monitor your health and the effects of the medication.

These visits will include assessments to check for any adverse events such as stroke, heart attack, or bleeding.

5 imaging assessments

At 3 and 12 months after your TAVI procedure, you may undergo imaging tests to check for any changes in your heart valve.

These tests are performed only in certain centers and help assess the presence of subclinical valve thrombosis.

6 completion of the study

The study will conclude 12 months after your TAVI procedure.

At the end of the study, the results will be analyzed to determine the safety and effectiveness of the treatments.

Who Can Join the Study?

Provide informed consent before any study-specific procedures. This means you agree to participate after understanding the study details.
Be an adult, which means you are more than 18 years old, and able to understand and agree to participate in the clinical trial.
Have severe symptomatic aortic stenosis and be accepted for Transcatheter Aortic Valve Implantation (TAVI) with any approved TAVI devices after evaluation by the Heart Team at your center. Aortic stenosis is a condition where the heart’s aortic valve narrows, affecting blood flow.
Have at least one of the following additional health conditions:
- Diabetes Mellitus: A condition where your blood sugar levels are too high. You may have this if your fasting blood sugar is 126 mg/dl or higher, or if your blood sugar is 200 mg/dl or higher two hours after eating, or if you are being treated with medication for diabetes.
- Previous coronary artery disease: This includes conditions like heart attacks or stable chest pain, confirmed by tests or imaging.
- Previous peripheral arterial disease: A condition affecting blood flow to your limbs, confirmed by tests or imaging.
Have had a successful TAVI procedure done through any vascular access. This means the procedure to replace your heart valve was completed successfully.
Not be participating in any other clinical trial or research study, although being part of registries is allowed.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to any of the study medications.
Patients who have had a stroke or transient ischemic attack (TIA) in the past 6 months. A TIA is sometimes called a “mini-stroke” and is a temporary period of symptoms similar to those of a stroke.
Patients with a recent heart attack in the past 6 months.
Patients with active bleeding or a high risk of bleeding.
Patients with severe liver disease. The liver is an organ that helps process substances in the body.
Patients with uncontrolled high blood pressure. This means blood pressure that is not managed well with medication or lifestyle changes.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Clinico San Carlos	Madrid	Spain
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Hospital Del Mar	Barcelona	Spain
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
IRCCS Policlinico San Donato	San Donato Milanese	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Alvaro Cunqueiro	Vigo	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Unidade Local De Saude Do Alentejo Central E.P.E.	Évora	Portugal
Huyfhdkv Ujuupulvsmqdt Dg Lg Pqvbnwha	Madrid	Spain
Hahojmoo Uwdzfiwoahwyx Mgjfizm Di Vqrbkyixyt	Santander	Spain
Hfecmrgy Dz Lr Sfdje Cegc I Sukx Pmo	Barcelona	Spain
Hgjrwqpi Uxewixsnigooa Hjsnwylk Taiao y Pbigog Icuvmvgp Cizhbo dpkyspmljheufphqm (vsbc	Badalona	Spain
Hydrnevy Uhcmnxxrrrgpb db A Cnjnzl	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	21.01.2022
Portugal	Not yet recruiting	21.01.2022
Spain	Recruiting	21.01.2022

Trial locations

Investigated drugs:

Ticagrelor is a medication that helps prevent blood clots. It works by stopping platelets, which are small blood cells, from sticking together. This is important because it can help reduce the risk of heart attacks or strokes, especially after certain heart procedures like the one in this trial. In this study, Ticagrelor is being tested to see how well it works compared to another medication in preventing serious health problems after a heart valve procedure.

Aspirin is a common medication that is often used to relieve pain and reduce fever. In this trial, it is being used for its ability to prevent blood clots. Aspirin helps keep blood flowing smoothly by stopping platelets from clumping together. This can help prevent heart attacks and strokes. The study is looking at how effective Aspirin is compared to another medication in preventing complications after a heart valve procedure.

Investigated diseases:

Aortic stenosis

Severe Symptomatic 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 become less efficient. As the condition progresses, individuals may experience symptoms such as chest pain, shortness of breath, and fainting, especially during physical activity. The severity of symptoms can increase as the valve becomes more obstructed. In severe cases, the heart may struggle to pump enough blood to meet the body’s needs, leading to fatigue and reduced physical activity tolerance. The progression of the disease can vary, but it typically worsens over time if left untreated.

Trial ID:

2023-509290-22-00

Protocol code:

REAC-TAVI 2

NCT ID:

NCT05283356

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ticagrelor and Aspirin for Patients with Severe Aortic Stenosis After Heart Valve Replacement

What is this study about?

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