Not yet recruiting

Preventing atrial fibrillation after cardiac surgery using colchicine, amiodarone and posterior pericardiotomy in adult patients

Registered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study focuses on preventing atrial fibrillation, a common irregular heart rhythm that often appears after heart surgery. The aim is to find out whether adding specific treatments can lower the number of patients who develop this condition during their hospital stay.

Participants receive either the usual post‑surgery care, which may include medicines such as bisoprolol and an injection of heparin, a surgical opening of the pericardial sac called posterior pericardiotomy, or a combination treatment that adds two oral drugs—colchicine and amiodarone—to the same surgical procedure.

After the operation, patients are randomly placed into one of the three groups and are observed for about a week while doctors monitor their heart rhythm and any side effects. The study records whether episodes of the irregular rhythm occur, how long the hospital stay lasts, and any problems related to the heart or digestive system.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomisation
After joining the study you will be placed at random into one of three groups: standard care, posterior pericardiotomy, or the treatment bundle that includes colchicine, amiodarone and posterior pericardiotomy.
Step 2
Background medication start
Every participant receives the background medication bisoprolol 20 mg taken by mouth once daily.
In addition, an intravenous infusion of heparin 600 000 U is given according to the protocol during the hospital stay.
Step 3
Surgical procedure (if assigned)
If you are in the posterior pericardiotomy group or the treatment‑bundle group, the surgeon creates a posterior pericardial window during the cardiac operation. this procedure is performed as part of the planned surgery.
Step 4
Treatment bundle medication start (if assigned)
If you are in the treatment‑bundle group you will begin two additional oral medicines after surgery:
colchicine 1 mg taken by mouth as directed,
amiodarone 400 mg taken by mouth as directed.
Step 5
Post‑operative monitoring
For up to seven days after the operation you will be monitored continuously with telemetry to detect any episode of atrial fibrillation lasting more than 30 minutes.
The medical team will also record any other heart rhythm problems, need for additional anticoagulants, or gastrointestinal symptoms.
Step 6
Medication continuation during hospital stay
You will continue to take the assigned oral medicines (bisoprolol, and if applicable colchicine and amiodarone) and receive intravenous heparin according to the study schedule until discharge or until the protocol‑specified end date.
Step 7
Discharge and final assessment
At the time of discharge the study staff will document any occurrence of atrial fibrillation, length of hospital stay, and any adverse events that occurred during the monitoring period.

Who can join the trial?

4 criteria

Be an adult (18 years old or older) who is staying in the hospital for heart surgery on the main artery (aorta), the arteries that supply the heart (coronary), the upward‑going part of the aorta (ascending aortic), or surgery that repairs or replaces the heart’s valves (valvular heart surgery).
Understand the French language well enough to follow the study information.
Be covered by French Social Security, which is the national health insurance system.
Sign a written document that shows you have been told about the study and agree to take part (written informed consent).

Who cannot join the trial?

13 criteria

Being in a vulnerable group, such as pregnant women or people who cannot make decisions for themselves
Having a medical reason that makes taking colchicine unsafe (colchicine is a medication used to reduce inflammation)
Not agreeing to let the study team use your personal health information for quality checks
Currently taking medicines that suppress the immune system, such as cyclosporine (these are called immunosuppressive therapies)
Women who could become pregnant, are sexually active with a male partner, and are not using a highly reliable method of birth control (contraception)
Having a medical reason that makes taking amiodarone unsafe (amiodarone is a medication used to control heart rhythm)
Already taking amiodarone or colchicine at the time of the study
Will have emergency heart surgery within the next 24 hours
Will have surgery on the mitral or tricuspid heart valve (these are valves that help blood flow through the heart)
Will undergo a Transcatheter Aortic Valve Implantation (TAVI), a procedure to replace the aortic valve without open‑heart surgery
Has an active severe infection of the bloodstream or heart lining, known as sepsis or endocarditis
Has had atrial fibrillation before (a type of irregular heartbeat)
Has a medical reason that makes the posterior pericardial window surgery unsafe (this is a surgical opening made behind the heart sac)

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Bisoprolol
is a medication that belongs to a group called beta‑blockers. It helps to slow down the heart rate and lower blood pressure, which can make the heart work more smoothly after surgery. In this study it is given to all participants as part of the usual care.
Heparin
is a medicine that prevents blood from clotting. It is given through a vein during and after heart surgery to reduce the chance of dangerous clots forming.
Amiodarone
is a drug used to keep the heart’s rhythm regular. It is taken after surgery to try to stop the heart from developing an irregular rhythm called atrial fibrillation.
Colchicine
is an anti‑inflammatory medication. In this trial it is used after surgery to lower inflammation, which can help lower the risk of atrial fibrillation.
Posterior pericardiotomy
is a small surgical procedure that creates an opening in the back part of the heart’s covering (the pericardium). This opening allows extra fluid to drain away, which can reduce swelling and irritation that might trigger atrial fibrillation.

What is already known about the treatment

Bisoprolol
This medication is taken as a film‑coated tablet swallowed by mouth. It is a well‑established beta‑1 selective blocker that is widely used and described in medical literature for treating high blood pressure, chest pain, and certain heart rhythm problems. It works by attaching to beta‑adrenergic receptors on heart cells, slowing the heart rate and reducing the heart’s workload. Pharmacologically it belongs to the class of beta‑blockers.
Amiodarone
This drug comes as an oral tablet that is swallowed. It is a commonly prescribed anti‑arrhythmic agent with a long history of study for preventing irregular heartbeats such as atrial fibrillation. At the molecular level it blocks several ion channels (potassium, sodium, calcium) and also has mild beta‑blocking effects, which together prolong the heart’s electrical reset period. It is classified as a class III anti‑arrhythmic medication.
Colchicine
The medication is provided as a small tablet taken by mouth. It is an approved anti‑inflammatory drug that is well known for treating gout attacks and pericarditis, and it is being tested here to help prevent postoperative atrial fibrillation. It works by binding to tubulin, preventing the formation of microtubules, which reduces the activity of white blood cells that cause inflammation. Its pharmacological class is an anti‑inflammatory agent (microtubule inhibitor).
Heparin
This product is a clear solution for injection given intravenously. It is a long‑standing anticoagulant that is extensively documented for preventing blood clots during surgeries and other high‑risk situations. Heparin enhances the activity of antithrombin, a natural protein that blocks thrombin and factor Xa, thereby stopping clot formation. It belongs to the class of anticoagulants (unfractionated heparin).

Investigated diseases

Atrial fibrillation - Atrial fibrillation is an abnormal heart rhythm where the upper chambers beat irregularly and often rapidly. This irregular beating can cause the heart to pump less efficiently and may lead to episodes that last from minutes to many hours. The condition can begin with occasional brief episodes and may progress to longer or more frequent episodes over time. After cardiac surgery, the likelihood of developing new or worsening episodes can increase during the early postoperative period. Episodes may persist for more than 30 minutes, indicating a more sustained form of the rhythm disturbance.