This clinical trial is focused on patients with atrial fibrillation, a condition where the heart beats irregularly. These patients have undergone a procedure called percutaneous coronary intervention (PCI), which is a type of surgery to restore blood flow to the heart using a stent. The study is investigating the use of a single drug that prevents blood clots, known as a P2Y12 inhibitor, followed by a direct-acting oral anticoagulant (DOAC). The medications being studied include rivaroxaban, ticagrelor, edoxaban, dabigatran, apixaban, clopidogrel, prasugrel, and acetylsalicylic acid.
The purpose of the study is to assess the safety and effectiveness of this treatment approach compared to the current standard treatment, which involves using a combination of medications to prevent blood clots. The study will follow patients for a period of 15 months to monitor for any major heart or brain events, such as heart attacks or strokes, as well as any significant bleeding events. The trial will also compare the outcomes of using the P2Y12 inhibitor alone for one month, followed by the DOAC alone for a longer period, against the standard treatment that involves multiple medications over several months.
Participants in the study will receive either the new treatment approach or the standard treatment. The study will help determine if the new approach is as safe and effective as the current standard. This research is important for improving treatment options for patients with atrial fibrillation who have undergone PCI, potentially leading to better health outcomes and fewer complications.
1joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, medical history of atrial fibrillation, and recent coronary intervention.
Written consent is required to participate.
2initial treatment phase
For the first month, a single drug that prevents blood clot formation, known as a P2Y12 inhibitor, is administered.
This medication is taken orally.
3transition to long-term treatment
After the initial month, the treatment shifts to a long-term regimen with a direct-acting oral anticoagulant (DOAC).
This phase continues for the remainder of the study period.
4standard care comparison
The study compares the new treatment approach to the current standard care, which involves a combination of three drugs for up to one month, followed by two drugs for 6 to 12 months, and then a single drug.
The standard care includes aspirin, a P2Y12 inhibitor, and a DOAC.
5monitoring and follow-up
Throughout the study, monitoring for major cardiac or cerebral events and bleeding is conducted.
The study duration is up to 15 months, with regular follow-ups to assess safety and effectiveness.
Who Can Join the Study?
Must be 18 years or older.
Have a condition called atrial fibrillation or flutter, which is a type of irregular heartbeat, and need to take a specific type of blood thinner called direct-acting oral anticoagulants (DOACs) for at least 12 months.
Have had a successful percutaneous coronary intervention (PCI), which is a procedure to open up blood vessels in the heart, in at least one area within the last 7 days, with no other areas needing treatment.
Must not have had any major problems after the PCI, such as new chest pain that might be due to heart issues, a blood clot in the stent, or new signs of nerve problems.
Must provide written informed consent, which means agreeing to participate in the study after understanding what it involves.
Who Cannot Join the Study?
Patients who have not undergone a successful PCI (a procedure to open blocked blood vessels in the heart).
Patients who are not indicated for treatment with a DOAC (a type of blood thinner) after receiving a sirolimus-eluting Supraflex Cruz stent.
Patients who are not diagnosed with AF (a condition where the heart beats irregularly).
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
P2Y12 Inhibitor is a type of medication that helps prevent blood clots by stopping platelets in the blood from sticking together. In this trial, it is used as a monotherapy for one month to see if it can safely reduce the risk of bleeding and prevent major heart and brain events in patients with atrial fibrillation who have had a coronary stent implanted.
Direct-Acting Oral Anticoagulant (DOAC) is a medication that helps prevent blood clots by thinning the blood. In this study, it is used after the initial P2Y12 inhibitor monotherapy. The trial aims to determine if using DOAC alone long-term is as effective and safe as the current standard treatment, which involves a combination of medications.
Atrial Fibrillation – Atrial fibrillation is a common heart rhythm disorder where the heart’s upper chambers (atria) beat irregularly and often rapidly. This can lead to poor blood flow and may cause symptoms like palpitations, shortness of breath, and fatigue. Over time, atrial fibrillation can increase the risk of stroke and heart failure. The condition can be persistent or occur in episodes, and its severity can vary among individuals. It often requires ongoing management to control the heart rate and reduce the risk of complications.
Myocardial Infarction – Myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This is usually due to a blockage in one or more of the coronary arteries. Symptoms often include chest pain, shortness of breath, and discomfort in the upper body. The severity of a heart attack can vary, and it can lead to significant heart damage if not addressed promptly. Recovery and progression depend on the extent of the damage and the individual’s overall health.
Stroke – A stroke happens when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can cause brain cells to die within minutes. Symptoms may include sudden numbness, confusion, trouble speaking, and difficulty walking. Strokes can be classified as ischemic, due to a blockage, or hemorrhagic, due to bleeding. The effects of a stroke depend on the area of the brain affected and the extent of the damage. Early intervention is crucial to minimize long-term effects.
Stent Thrombosis – Stent thrombosis is a rare but serious complication that occurs when a blood clot forms on a stent placed in a coronary artery. This can lead to a sudden blockage of the artery, potentially causing a heart attack. It can occur shortly after stent placement or even months later. Symptoms may include chest pain and other signs of a heart attack. The risk of stent thrombosis can be influenced by factors such as stent type, patient health, and adherence to prescribed medications.
Transient Ischemic Attack – A transient ischemic attack (TIA), often called a mini-stroke, occurs when there is a temporary decrease in blood supply to part of the brain. Symptoms are similar to those of a stroke but are temporary and usually resolve within minutes to hours. TIAs do not cause permanent damage but are often a warning sign of a future stroke. They can be caused by a variety of factors, including blood clots and narrowed blood vessels. Recognizing and addressing the underlying causes of a TIA is important to prevent a full stroke.
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