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Study on Stopping Anticoagulants in Atrial Fibrillation Patients After Surgery: Warfarin, Rivaroxaban, Apixaban, Edoxaban, Dabigatran, and Drug Combination

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with atrial fibrillation, a common heart condition that causes an irregular and often rapid heart rate. The study is investigating whether patients who have undergone a specific type of heart surgery, known as surgical closure of the left atrial appendage, can safely stop taking blood-thinning medications. These medications, also known as anticoagulants, help prevent blood clots that can lead to strokes. The trial will compare the risks of stroke, blood clots, and major bleeding events in patients who continue taking these medications versus those who do not.

The medications being studied include Warfarin Sodium, a vitamin-K antagonist, and several direct factor Xa inhibitors: Rivaroxaban, Apixaban, and Edoxaban. Additionally, Dabigatran, a direct thrombin inhibitor, is also part of the study. These medications are commonly used to prevent blood clots in patients with atrial fibrillation. Some participants in the study will receive a placebo, which is a substance with no active medication, to help researchers understand the effects of the actual medications.

The study will last for a period of up to 48 months, during which participants will be monitored for any occurrences of stroke, blood clots, or bleeding events. The goal is to determine if it is safe for patients to discontinue anticoagulant therapy after their heart surgery. This research could potentially lead to changes in how patients with atrial fibrillation are treated following surgery, aiming to improve their quality of life and reduce the risk of complications associated with long-term use of blood-thinning medications.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, the patient will be informed about the study's purpose and procedures. The patient will provide informed consent, confirming understanding and agreement to participate.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes reviewing medical history, particularly any previous cardiac surgeries and atrial fibrillation diagnosis.
Step 3
Randomization
The patient will be randomly assigned to one of two groups: one group will continue with anticoagulant therapy, and the other group will discontinue it. This process ensures that the study results are unbiased.
Step 4
Medication administration
If assigned to the anticoagulant therapy group, the patient will take one of the following medications orally: warfarin sodium, rivaroxaban, apixaban, edoxaban, or dabigatran. The specific dosage and frequency will be determined by the study team based on individual needs.
Step 5
Regular follow-ups
The patient will attend regular follow-up appointments to monitor health status. These appointments will include assessments for any signs of stroke, embolisms, or bleeding events.
Step 6
Final assessment
At the end of the trial period, a final assessment will be conducted. This will evaluate the patient's overall health and any effects of continuing or discontinuing anticoagulant therapy.

Who can join the trial?

4 criteria

Must be older than 18 years.
Must have had a heart surgery that included closing the left atrial appendage. This could have been done using different methods like cutting and stitching, using a stapler, stitching without cutting, or using a special device like the AtriClip. This surgery should have been done between January 1, 2010, and April 1, 2023.
Must have a recorded history of atrial fibrillation or atrial flutter. These are conditions where the heart beats irregularly or too fast.
Must agree to participate by giving informed consent, which means understanding the study and agreeing to take part.

Who cannot join the trial?

4 criteria

Patients who have not been diagnosed with atrial fibrillation. Atrial fibrillation is a condition where the heart beats in an irregular and often rapid manner.
Patients who have not undergone a surgical procedure called left atrial appendage closure. This is a surgery to close a small pouch in the heart to reduce the risk of stroke.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means groups that may need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Aarhus University Hospital
Verified
Aarhus, Denmark
Gentofte Hospital
Verified
Hellerup, Denmark

Trial locations

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Investigated drugs

Anticoagulant therapy is a treatment that helps prevent blood clots from forming in your blood vessels. This is important for patients with atrial fibrillation, a condition where the heart beats irregularly, which can lead to the formation of clots. These clots can travel to other parts of the body, like the brain, and cause serious problems such as a stroke. In this trial, anticoagulant therapy is being studied to see if it can reduce the risk of stroke and other complications in patients who have had a surgical procedure to close a part of the heart called the left atrial appendage.

What is already known about the treatment

Anticoagulant therapy – This medication is typically administered orally or through injection to prevent blood clots. It is currently being studied in clinical trials, such as the ATLAAC trial, to assess its effectiveness in patients with atrial fibrillation who have had surgical closure of the left atrial appendage. The main therapeutic use of anticoagulant therapy is to reduce the risk of stroke and systemic embolisms. At the molecular level, it works by inhibiting certain proteins in the blood that are necessary for clot formation. Anticoagulants are classified as blood thinners in pharmacology.

Investigated diseases

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, known as the atria, beat out of sync with the lower chambers, or ventricles. This irregular rhythm can lead to poor blood flow and may cause symptoms such as palpitations, shortness of breath, and fatigue. Over time, atrial fibrillation can contribute to the formation of blood clots in the heart, which can travel to other parts of the body and cause complications. The condition can be persistent or occur in episodes, and its severity can vary among individuals. It is a common condition, especially in older adults, and can be associated with other heart-related issues.