Besancon University Hospital Center
Besançon, France
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
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.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
4 criteria
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Besançon, France
La Tronche, France
Pau, France
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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.
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