Study on Edoxaban for Patients with Atrial Fibrillation and Coronary Syndrome Undergoing PCI

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What is this study about?

This clinical trial is focused on patients with atrial fibrillation, a condition where the heart beats irregularly, and those experiencing acute coronary syndrome or chronic coronary syndrome, which are types of heart problems. The study is investigating the use of a medication called Lixiana, which contains the active substance edoxaban. This medication is available in two forms: 30 mg and 60 mg film-coated tablets. The purpose of the study is to find the best way to prevent blood clots in these patients, especially after they have undergone a procedure called percutaneous coronary intervention (PCI), which is used to open blocked heart arteries.

Participants in the study will be given either the standard treatment or a new treatment strategy involving Lixiana. The study will compare the safety and effectiveness of these treatments by looking at the risk of bleeding and the occurrence of heart-related events like heart attacks or strokes. The study will last for several weeks, with follow-ups to check on the participants’ health and any side effects they might experience.

The trial aims to provide valuable information on how to best manage patients with these heart conditions, ensuring they receive the safest and most effective treatment. The results will help doctors make informed decisions about using Lixiana in patients with atrial fibrillation and heart syndromes, especially after they have had a PCI procedure.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures of the trial. You will be asked to provide consent to participate.

You will undergo an initial assessment to confirm eligibility, which includes being at least 18 years old, having undergone a successful percutaneous coronary intervention (PCI), and having a history of or newly diagnosed atrial fibrillation or flutter.

2 medication administration

You will be assigned to receive either a 30-day dual antiplatelet therapy (DAPT) or standard therapy. The specific medications and dosages will be explained to you by the study team.

You will take Lixiana tablets, which contain the active substance edoxaban. The dosage will be either 30 mg or 60 mg, taken orally as directed by the study team.

3 follow-up visits

You will have follow-up visits scheduled at 6 weeks and 6 months after the PCI procedure. These visits are to monitor your health and assess the safety and effectiveness of the treatment.

During these visits, you will be evaluated for any bleeding events and other health outcomes such as heart attack, stroke, or stent-related issues.

4 end of participation

Your participation in the study will conclude after the final follow-up visit at 6 months. The study team will provide you with any necessary information regarding your health and future care.

You will be informed about the overall results of the study once it is completed and analyzed.

Who Can Join the Study?

  • Must be 18 years of age or older.
  • Must have had a successful PCI. (PCI stands for Percutaneous Coronary Intervention, a procedure to open blocked blood vessels in the heart.)
  • Must have a history of or newly diagnosed atrial fibrillation or flutter. (Atrial fibrillation or flutter is a condition where the heart beats irregularly.)
  • Must have a long-term need for OAC. (OAC stands for Oral Anticoagulation, which is medication to prevent blood clots.)

Who Cannot Join the Study?

  • Patients with atrial fibrillation (a condition where the heart beats irregularly) cannot participate.
  • Patients with acute coronary syndrome (a range of conditions associated with sudden, reduced blood flow to the heart) cannot participate.
  • Patients with chronic coronary syndrome (a condition where the heart’s blood supply is blocked or reduced over time) cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Stichting OLVG Amsterdam The Netherlands
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium

Other Sites

Site Name City Country Status
Az Maria Middelares Gent Gent Belgium
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Centre Hospitalier Regional De La Citadelle Liege Belgium
Ospedale “Morgagni – Pierantoni” di Forlì Forli' Italy
Hsrw Htcsvadr Hague The Netherlands
Urvifnahlzap Mhrejsw Cwejfeb Uncymgz Utrecht The Netherlands
Adfajvi Otozfpzjipxhfthqifhpqfzce Mgiaqdof Djdjm Cbkzin Novara Italy
Utgfkwtxyt Ow Amrwbvk Edegem Belgium
Vljwt Udbuyuyqvzgd Bbknage Jette Belgium
Adzusthj Zifzrfrtpj Dpysq Roeselare Belgium
Avobruvu Zxpqguysha Gbjmmwbon Kortrijk Belgium
Mzqjiev Sxpupdtz Tgfwag Enschede The Netherlands
Olzqrdyz Mw Bptpazvc Cesena Italy
Urfjisuvfl Hezndmzp Oz Psswd Parma Italy
Sich Ainxgt Hqmbubgd La Spezia Italy
Hnkzst Charleroi Belgium
Rtdhlyb Tszpspncreddv Mgooypjx Bqys Nijmegen The Netherlands
Cfsqhmvxy Zrresqrahv Spagamllg Eindhoven The Netherlands
Amelsl Utkvqkfgyx Hxdbrtpu Aarhus Denmark
Uqaqvceasexwhkael Ds Pqch Pisa Italy
Aiwsfrfdu Uvj Amsterdam The Netherlands
Jgq Ybsjuwt Zfajubkwxl Ieper Belgium
Ahsroyk Ugd Tvxqcep Cqomwi Prato Italy
Ckw Mcseaiyjq Liege Belgium
Soagfktng Tnrhpg Zgburepgbrqsax Emmen The Netherlands
Zvqivtrynq Ofvr Lbugckx Genk Belgium
Abbzoso Uuh Ignnu Df Rmiklb Eemzwv Reggio Emilia Italy
Avjtdvr Uskyo Syavkxbzr Lnkxld Duwjn Rvxrglj Faenza Italy
Ngizoozqk Zpbytnduyhrozxp Shpkwvryx Alkmaar The Netherlands
Laojj Udiltaiqasyd Mqmrhbe Cvfeapk (twmba Leiden The Netherlands
Icwiq Kafpzkoas Snjbrvxin Zwolle The Netherlands
Hpcfaxtr Smigt Milby Dhine Magpzhoxommm Perugia Italy
Txluvkvqpojxpupzqkc Hilversum The Netherlands
Rizmatde Ujkamivlxj Roskilde Denmark
Istbcz Bonheiden Belgium
Sthmyxqvr Vwguuka Mwlmsnw Ciflimt vyix Nnnesqngljiuc Venlo The Netherlands
Ersixvhadlkzsfzonahe Zpatisunix Tilburg The Netherlands
Zwbfvla Uvzjafnrla Hhtnblxq Koege Denmark

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
25.11.2022
Denmark Denmark
Recruiting
25.11.2022
Italy Italy
Recruiting
25.11.2022
The Netherlands The Netherlands
Recruiting
25.11.2022

Trial locations

DAPT is a therapy that involves taking two medications together to prevent blood clots. This therapy is often used for people who have had a heart procedure called percutaneous coronary intervention (PCI) or who have a condition called atrial fibrillation (AF). The goal of DAPT is to reduce the risk of heart attacks or strokes by keeping the blood flowing smoothly through the arteries.

Atrial fibrillation – Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) beat out of coordination with the lower chambers (ventricles). This can lead to poor blood flow and may cause symptoms such as heart palpitations, shortness of breath, and fatigue. Over time, atrial fibrillation can lead to complications like blood clots and heart failure. The condition can be intermittent or persistent, with episodes that may last from minutes to hours or even longer. It often requires ongoing monitoring to manage its progression.

Acute coronary syndrome – Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It includes situations where the heart muscle is at risk of damage due to insufficient oxygen supply. This condition often presents with chest pain or discomfort, which may radiate to other parts of the body. The progression can lead to more severe heart problems, such as a heart attack, if not addressed promptly. It is typically a result of the buildup of fatty deposits in and on the walls of coronary arteries. The condition requires immediate medical attention to prevent further heart damage.

Chronic coronary syndrome – Chronic coronary syndrome refers to a group of conditions that result from long-term reduction in blood flow to the heart muscle. It is often caused by the gradual buildup of plaque in the coronary arteries, leading to narrowed or blocked arteries. This can cause symptoms like chest pain or discomfort, especially during physical activity or stress. Over time, the reduced blood flow can weaken the heart muscle and lead to heart failure. The condition is typically stable but can become unstable if the plaque ruptures or if a blood clot forms. Management focuses on preventing progression and maintaining heart health.

Trial ID:
2022-502140-13-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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