Study on Long-Term Anticoagulation with Rivaroxaban vs. Acetylsalicylic Acid for Patients at Risk of Stroke After Atrial Fibrillation Ablation

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What is this study about?

This clinical trial is focused on patients who have undergone a procedure called catheter ablation to treat atrial fibrillation, a condition that can increase the risk of having a stroke. The study is investigating two different treatments to see which is more effective in reducing the risk of stroke and other related events. The first treatment involves the use of a medication called rivaroxaban, which is a type of blood thinner that helps prevent blood clots. The second treatment uses acetylsalicylic acid, commonly known as aspirin, which is also used to prevent blood clots but works in a different way.

The purpose of the study is to determine whether continuing long-term treatment with rivaroxaban is better than using acetylsalicylic acid alone in preventing strokes and other similar events in patients who are at moderate risk after their successful catheter ablation. Participants in the study will be randomly assigned to receive either rivaroxaban or acetylsalicylic acid. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will last for up to 36 months, during which time participants will have regular check-ups and tests to monitor their health and the effects of the treatment.

The main goal is to see if there is a difference in the occurrence of strokes or other related events between the two treatment groups. The study will also look at other outcomes, such as the occurrence of bleeding, changes in brain scans using MRI, and overall quality of life. This information will help doctors understand the best way to prevent strokes in patients who have had atrial fibrillation and have undergone catheter ablation.

1 enrollment

The trial begins with the enrollment of patients who meet specific criteria. These include being at least one year post-successful catheter ablation for atrial fibrillation, having a CHA2DS2-VASc risk score of 1 or more, being over 18 years of age, and having non-valvular atrial fibrillation.

2 medication administration

Participants will receive either ongoing, long-term oral anticoagulation or antiplatelet therapy alone. The medications used are acetylsalicylic acid (ASS-ratiopharm® 100 mg tablets) and rivaroxaban (Xarelto 15 mg film-coated tablets). Both medications are taken orally.

3 monitoring and assessments

Throughout the trial, participants will undergo regular monitoring to assess the effectiveness of the treatment. This includes evaluating the occurrence of stroke, systemic embolism, and covert embolic stroke through cerebral magnetic resonance imaging (MRI).

Secondary assessments include monitoring for clinical stroke, covert MRI strokes larger than 15 mm, bleeding events, transient ischemic attacks, and overall mortality. Additional evaluations involve neuropsychological testing and quality of life assessments.

4 completion

The trial is expected to conclude by July 31, 2025. At the end of the trial, data will be analyzed to determine the net clinical benefit of the treatment strategies, focusing on the reduction in stroke and transient ischemic attack rates compared to major bleeding events.

Who Can Join the Study?

  • The patient must be at least one year after a successful procedure called catheter ablation for a heart condition known as atrial fibrillation. This means there should be no signs of irregular heartbeats, confirmed by specific heart tests called Holter and ECG, at different times after the procedure.
  • The patient must have a CHA2DS2-VASc risk score of 1 or more. This is a score used to estimate the risk of stroke in people with atrial fibrillation. However, if the only risk factors are being female or having vascular disease, the patient cannot participate.
  • The patient must be older than 18 years.
  • The patient must have a type of atrial fibrillation that is not caused by a problem with the heart valves, known as non-valvular atrial fibrillation.

Who Cannot Join the Study?

  • Patients who have had a recent stroke or mini-stroke (also known as a transient ischemic attack or TIA). A stroke is when blood flow to a part of the brain is stopped, and a mini-stroke is a temporary period of symptoms similar to those of a stroke.
  • Patients with a history of bleeding disorders. These are conditions that affect the way your blood clots, which can lead to excessive bleeding.
  • Patients who have severe liver disease. The liver is an organ that helps with digestion and filtering toxins from the blood, and severe disease can affect its function.
  • Patients with kidney disease that requires dialysis. Dialysis is a treatment that does the work of the kidneys if they are not functioning properly.
  • Patients who are pregnant or breastfeeding. Pregnancy and breastfeeding involve changes in the body that can affect how treatments work.
  • Patients who are unable to follow the study procedures or take the study medication as required. This means they might not be able to attend appointments or take the medication as instructed.
  • Patients who are participating in another clinical trial. Being in more than one trial at a time can affect the results of the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Klinikum Coburg GmbH Coburg Germany
Asklepios Klinik St George Hamburg Germany
Algemeen Ziekenhuis Delta Roeselare Belgium
Az Maria Middelares Gent Gent Belgium
Gemeinnuetzige Gesellschaft der Franziskanerinnen zu Olpe mbH Bonn Germany
Herzzentrum Leipzig GmbH Leipzig Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Jessa Ziekenhuis Hasselt Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Ziekenhuis Oost Limburg Genk Belgium
Upwmapceut Mylrlab Cwwayi Hlsgqqkspkifxadqz Hamburg Germany
Shrzrrfayc Kbkgalqp Bad Segeberg Germany
Ustxfwvokn Hhruvbhg Ciqnfny Cologne Germany
Uekgzwaumx Ok Aaabnwk Edegem Belgium
Cisndygty dj Sksvfpfuapvrfu Arlon Belgium

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.12.2018
Germany Germany
Not recruiting
01.12.2018

Trial locations

Oral Anticoagulation is a type of medication used to prevent blood clots. In this trial, it is being tested to see if it is more effective than antiplatelet therapy in reducing the risk of stroke or other embolic events in patients who have undergone catheter ablation for atrial fibrillation. This medication works by thinning the blood, which helps to prevent clots from forming.

Antiplatelet Therapy (ASA), commonly known as aspirin, is used to prevent blood clots by stopping platelets from clumping together. In this trial, it is being compared to oral anticoagulation to determine if it is sufficient on its own to reduce the risk of stroke or other embolic events in patients after catheter ablation for atrial fibrillation.

Atrial Fibrillation – Atrial fibrillation is a common heart rhythm disorder where the heart’s upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and increase the risk of blood clots forming in the heart. These clots can travel to other parts of the body, including the brain, potentially causing a stroke. The condition may be persistent or occur in episodes, and symptoms can include palpitations, fatigue, and shortness of breath. Over time, atrial fibrillation can weaken the heart and lead to heart failure. It is often associated with other heart-related conditions such as high blood pressure or heart disease.

Trial ID:
2024-518736-37-00
Protocol code:
OHIRC-20150866
NCT ID:
NCT02168829
Trial Phase:
Therapeutic confirmatory (Phase III)

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