Study on Edoxaban and Drug Combination for Patients with Atrial Fibrillation Needing Anticoagulation After Cardiac Surgery

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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, who need to take blood-thinning medications after having heart surgery. The study is comparing two types of blood thinners: Direct Oral Anticoagulants (DOACs) and Vitamin K Antagonists (VKAs). The medications being studied include Edoxaban, Apixaban, Dabigatran, Rivaroxaban, Warfarin, and Phenprocoumon. These medications help prevent blood clots, which can lead to serious health problems like strokes.

The purpose of the study is to evaluate the safety of using DOACs compared to VKAs in patients who have undergone heart surgery and have atrial fibrillation. Participants in the study will be randomly assigned to receive either a DOAC or a VKA. The study will last for about 90 days, during which the safety of these medications will be closely monitored. This includes checking for any major bleeding events or other complications that might occur.

Throughout the study, researchers will also look at other health outcomes, such as the occurrence of strokes or other types of blood clots, and overall patient satisfaction with their treatment. The study aims to provide valuable information on which type of blood thinner is safer and more effective for patients with atrial fibrillation after heart surgery.

1 enrollment

Eligibility is confirmed based on criteria such as age (18 years or older), recent open heart surgery (within the last 10 days), and a need for anticoagulation due to atrial fibrillation.

Informed consent is obtained from the patient or a substitute decision-maker.

2 randomization

Participants are randomly assigned to receive either a direct oral anticoagulant (DOAC) or a vitamin K antagonist (VKA).

The specific medication and dosage are determined by the study protocol.

3 medication administration

Participants take the assigned medication orally as prescribed.

Medications include edoxaban, apixaban, dabigatran, warfarin, rivaroxaban, and phenprocoumon.

4 monitoring and follow-up

Participants are monitored for any major bleeding events at 30 days, which include bleeding that results in death, requires reoperation, or leads to hospitalization.

Secondary outcomes such as stroke, embolism, and other complications are assessed at 30 and 90 days, and at 6 months.

5 quality of life and satisfaction assessment

Participants complete the EQ-5D-5L questionnaire to evaluate quality of life.

Satisfaction with anticoagulant treatment is assessed using the Perception of Anticoagulant Treatment Questionnaire (PACT-Q).

6 trial completion

The trial is expected to conclude by July 31, 2027.

Final assessments and data collection are conducted to evaluate the safety and effectiveness of the treatments.

Who Can Join the Study?

Must be 18 years or older at the time of joining the study.
Must have had open heart surgery within the last 10 days.
Must have atrial fibrillation, which is a type of irregular heartbeat, that requires treatment with blood-thinning medication.
Must provide informed consent, which means agreeing to participate after understanding the study, either by the patient or someone who can make decisions for them.

Who Cannot Join the Study?

Patients who have atrial fibrillation (a type of irregular heartbeat) and need to take blood-thinning medication.

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 Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Herzzentrum Leipzig GmbH	Leipzig	Germany
Usnprgsxsa Mwagczr Cfoccm Hlsdgrsmyeltywmtm	Hamburg	Germany
Uolnvtxapkmznnzypgrbs Ebjdd Aca	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	15.08.2023

Trial locations

Investigated drugs:

Direct Oral Anticoagulants (DOAC) are a group of medications used to prevent blood clots. They work by directly inhibiting specific clotting factors in the blood, which helps to reduce the risk of stroke and other complications in patients with atrial fibrillation (AF) after cardiac surgery. These medications are taken orally and are known for having fewer dietary restrictions and interactions compared to other anticoagulants.

Vitamin K Antagonists (VKA) are a type of medication that helps prevent blood clots by reducing the action of vitamin K, which is necessary for blood clotting. They are commonly used in patients with atrial fibrillation to prevent stroke and other clot-related issues after cardiac surgery. VKAs require regular blood tests to monitor their effect and may have dietary restrictions.

Investigated diseases:

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 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 management to prevent complications, especially in patients undergoing procedures like cardiac surgery.

Trial ID:

2023-504504-28-00

Protocol code:

2020.12.18

NCT ID:

NCT04284839

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Edoxaban and Drug Combination for Patients with Atrial Fibrillation Needing Anticoagulation After Cardiac Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?