Study on the Safety and Effectiveness of Short Dual Antiplatelet Therapy with Ticagrelor, Clopidogrel, and Prasugrel in Patients Aged 65+ with Coronary Artery Disease

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What is this study about?

This clinical trial is focused on older patients, aged 65 and above, who have undergone a procedure called percutaneous coronary intervention (PCI). This procedure involves placing a small tube called a stent in the heart’s blood vessels to help keep them open. The study is looking at patients who have received at least one drug-eluting stent, which is a type of stent that slowly releases medication to prevent the blood vessel from closing again. These patients may have had either an acute coronary syndrome, which includes conditions like heart attacks and unstable chest pain, or a chronic coronary syndrome, which involves long-term heart issues.

The purpose of the study is to compare two different approaches to preventing blood clots in these patients. One approach is a very short period of dual antiplatelet therapy (DAPT), which involves taking two medications that help prevent blood clots. This is followed by a single medication called a P2Y12 inhibitor. The study will compare this approach to the standard DAPT, which is usually taken for a longer period. The medications being studied include KARDEGIC (containing d,l-lysine acetylsalicylate), Brilique (ticagrelor), Plavix (clopidogrel), and Efient (prasugrel). The study will also involve a placebo group.

The trial will last for up to one year, during which the safety and effectiveness of the treatments will be monitored. The main goal is to see if the shorter treatment is as good as the standard treatment in terms of overall health benefits, including reducing the risk of death, heart attacks, strokes, and major bleeding. The study will also look at other outcomes, such as the need for additional heart procedures and hospitalizations. The results will help determine the best treatment approach for older patients who have undergone PCI.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Written informed consent is required to participate.

The patient must be at least 65 years old and have been successfully treated with a procedure called percutaneous coronary intervention (PCI), which involves placing a stent in the heart’s arteries.

2 randomization

Before leaving the study site, the patient will be randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

3 treatment phase

The patient will begin a treatment called dual antiplatelet therapy (DAPT), which involves taking two medications to prevent blood clots. The medications used are KARDEGIC 75 mg as an oral solution and one of the following tablets: Brilique 90 mg, Plavix 75 mg, or Efient 10 mg. These medications are taken orally.

The duration of this phase is very short, after which the patient will switch to a single medication, known as single antiplatelet therapy (SAPT), using a P2Y12 inhibitor such as Brilique, Plavix, or Efient.

4 follow-up and monitoring

Throughout the study, the patient’s health will be closely monitored to assess the safety and effectiveness of the treatment. This includes checking for any side effects or complications such as heart attacks, strokes, or bleeding.

The study aims to determine if the shorter DAPT followed by SAPT is as effective as the standard DAPT in preventing serious health events over a period of one year.

5 completion of the study

At the end of the study period, the patient’s overall health and any changes will be evaluated. The results will help determine the best treatment approach for older patients undergoing PCI.

Who Can Join the Study?

  • Patients must be 65 years or older.
  • Must have been successfully treated with percutaneous coronary intervention (PCI), which is a procedure to open up blood vessels in the heart, using at least one drug-eluting stent for either acute or chronic coronary syndrome. This means the blood flow in the heart is good and the narrowing in the blood vessel is less than 30%.
  • Randomization, which is the process of assigning patients to different treatment groups, must happen before leaving the study site.
  • Must provide written informed consent, meaning you agree to participate after understanding the study details.
  • Must be affiliated with social security.

Who Cannot Join the Study?

  • Patients who have not been successfully treated with percutaneous coronary intervention (PCI). This is a procedure to open up blood vessels in the heart.
  • Patients who have not received at least one drug-eluting stent. This is a small tube placed in the heart’s blood vessels to keep them open, which slowly releases medication.
  • Patients who are not 65 years or older.
  • Patients who have not been treated for acute or chronic coronary syndrome. This refers to conditions caused by reduced blood flow to the heart.

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
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Les Hopitaux De Chartres Le Coudray France
Clinique Saint Hilaire Rouen France
Centre Hospitalier Public Du Cotentin Cherbourg-En-Cotentin France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier De Pau Pau France
Hhvxlya Pgkgu Dz Lnleytjyiuqidvij Le Havre France
Baoamtco Uitglljpdz Hyilvksj Cbljve Besançon France
Cftxqp Huqippincey Rwzneyte Uqltmhykjqzty Dt Tslat Tours France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.01.2025

Trial locations

P2Y12 inhibitor is a type of medication used to prevent blood clots. It works by blocking a specific receptor on the surface of platelets, which are small blood cells that help with clotting. By blocking this receptor, the medication reduces the ability of platelets to stick together and form clots. This is particularly important for patients who have undergone procedures like percutaneous coronary intervention (PCI), where the risk of clot formation is higher. In this trial, the P2Y12 inhibitor is used as part of a strategy to reduce the risk of heart attacks, strokes, and other serious complications after the procedure.

Investigated diseases:

Coronary Artery Disease – This condition involves the narrowing or blockage of the coronary arteries, usually due to atherosclerosis, which is the buildup of cholesterol and fatty deposits on the artery walls. As the arteries narrow, blood flow to the heart muscle is reduced, which can lead to chest pain, known as angina. Over time, the reduced blood flow can cause damage to the heart muscle, potentially leading to a heart attack. The disease progresses as the plaque continues to build up, further narrowing the arteries and increasing the risk of heart-related complications. Symptoms may include shortness of breath, fatigue, and palpitations. The progression can be slow and may go unnoticed until significant artery blockage occurs.

Trial ID:
2023-507545-28-00
Protocol code:
23-0165
Trial Phase:
Therapeutic confirmatory (Phase III)

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