A Phase 3 interventional study of Colchicine and Amiodarone in Atrial Fibrillation (AF), sponsored by Elsan. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Elsan · Phase 3, Interventional, and Prevention
The goal of this clinical trial is to learn if a bundle of three treatments can prevent atrial fibrillation, a heart rhythm disorder often observed in adults following heart surgery. Atrial fibrillation is associated with increased risks of stroke and heart failure. The bundle consists of two drugs (colchicine and amiodarone) as well as a simple surgical technique called posterior pericardiotomy. The main question it aims to answer is whether this bundle can reduce the incidence of atrial fibrillation after heart surgery.
Researchers will compare the results from this bundle of treatment to two other groups, one treated only with the posterior pericardiotomy and one treated following standard of care.
Participants, depending on their group, may receive colchicine and amiodarone before and just after heart surgery and the posterior pericardiotomy will be performed at the same time as the heart surgery.
Atrial fibrillation (AF) is an irregular and often very rapid heart rhythm, and it is one of the most commonly encountered heart conditions. AF is defined as a supraventricular arrhythmia with uncoordinated atrial activation, which results in a loss of effective atrial contraction (Van Gelder et al. 2024). AF has been associated with increased risks of stroke and heart failure as well as subclinical cerebral damage (potentially leading to vascular dementia), and thromboembolism to every other organ (Van Gelder et al. 2024). POAF is associated with worsening prognostics as it is linked with prolonged hospital stay, haemodynamic instability, an increased risk of stroke, and increased mortality (Maesen et al. 2012; Caldonazo et al. 2023). The strongest predictor of POAF is increasing age, other predictors are more difficult to define as they are not always significantly correlated with POAF (Maesen et al. 2012).
Studies have assessed many different medical strategies to decrease POAF's incidence after cardiac surgery, resulting in a wide variety of treatments and prevention strategies that do not necessarily have robust proof of a positive effect. The goal of this study is to obtain more conclusive proof on the efficacy and safety of a treatment bundle in preventing POAF's incidence. This bundle will include treatment with amiodarone and colchicine as well as a surgical procedure (posterior pericardiotomy).
Amiodarone is an anti-arrhythmia treatment that has proven effective in POAF's prevention (Chatterjee et al. 2013). However, in Europe, it is rarely used for PAOF's prevention due to adverse events, including heart conduction disorders (Emiola et al. 2024). Low doses of amiodarone over a short period of time could help prevent POAF while decreasing the incidence of adverse events (Van Gelder et al. 2024). Amiodarone is sometimes used in combination with beta-blockers (Auer et al. 2004; Polintan et al. 2023). However, we have recently demonstrated that the use of beta-blockers during cardiac surgery can increase the incidence of postoperative acute renal failure and might not prevent POAF. Their use should remain cautious peri-operatively in the context of these high-risk surgeries (Guinot et al. 2024; Fischer et Guinot 2024).
Colchicine has an anti-inflammatory and anti-arrhythmic action by inhibiting microtubular depolymerization of the calcium channels involved in tachyarrhythmias. A recent meta-analysis highlights its efficacy in preventing POAF (Agarwal et al. 2023) and in some cases even for short treatment durations (5 days peri-operatively) (Shvartz et al. 2022).
The posterior pericardial window is a quick surgical technique (\<5 min) that helps drain pericardial fluid into the left pleura by making a 4-5 cm incision in the posterior pericardium opposite the left inferior pulmonary vein, towards the diaphragm, and parallel to the phrenic nerve. The advantage of this technique is that it avoids the accumulation of fluid opposite the left atrium, which can induce POAF, especially as postoperative pericardial fluid is itself highly inflammatory (Abouarab et al. 2017). A recent randomized study showed a significant reduction in POAF's incidence in patients who benefited from this procedure compared to patients who did not (Gaudino et al. 2021). However, no other randomized study has yet confirmed these results.
The originality of this study project lies in the evaluation of a "preventive treatment bundle" to reduce the incidence of POAF after cardiac surgery compared to the standard of care (which includes treatment with amiodarone and beta-blockers in case of POAF). This study will also compare the use of a posterior pericardial window with the standard of care. This will help to differentiate the impact of the posterior pericardial window versus the preventive treatment with amiodarone and colchicine on the incidence of POAF.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 636 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Elsan is the lead sponsor of 68 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Patients will be treated following standard of care with the addition of the posterior pericardiotomy performed during the planned surgery.
Procedure: Posterior pericardiotomy
Patients will receive amiodarone and colchicine for prevention and the posterior pericardial window will be performed during the surgery.
Drug: Colchicine · Drug: Amiodarone
The dosage will be 1mg PO on D-1, followed by 1mg/day PO from D1 to D5 (stopped in case of diarrhoea). This represents a maximum total dose of 6mg. If the patient is older than 75 years old or if the patient's weight is less than 70kg, then the daily dosage will be 0.5mg.
400mg/day per os (PO) on D-1 and D0, followed by 200mg/day PO from D1 to D5 if the heart rate is equal or superior to 70 beats/min. If the heart rate is inferior to 70 beats/min then the treatment will not be given. This represents a maximum total dose of 1800mg.
The procedure will be done similarly to previously published studies (Mulay et al. 1995; Gaudino et al. 2021). The left pleural space will be entered through the pre-existing median sternotomy. A 4-cm incision will be made posterior to the phrenic nerve in a parallel and longitudinal fashion extending from the left inferior pulmonary vein to the diaphragm. We will use the tip of the mediastinal tube that is placed in all cardiac surgery patients (instead of an additional chest tube) for drainage of the left-sided pleura so that patients in the treatment group will not have a higher level of postoperative pain or discomfort. The estimated additional surgery time is less than 5 min (Abouarab et al. 2017).
Difference in the number of patients presenting an episode of persistent AF between control group and the two experimental groups
The primary endpoint is the difference in the number of patients presenting an episode of persistent AF (defined as an AF episode lasting more than 30 minutes as documented by scopic and telemetric monitoring) during their hospitalisation. AF is defined by the ESC as RR interval irregularity, absence of repeated P waves, and irregular atrial activations. The SoC group will be compared to the other two groups of the study. Any episode of persistent AF will be recorded by the usual telemetric monitoring used in post-cardiac surgery monitoring and confirmed by a specialist's review of the trace.
Time frame: From enrollment to seven days after the surgery
Difference in the number of patients presenting an episode of persistent AF between the two experimental groups
Difference in the number of patients presenting an episode of persistent AF during the postoperative follow-up hospitalization after cardiac surgery, of the preventive treatment bundle (associating colchicine, amiodarone, and posterior pericardial window) compared to the posterior pericardial window alone.
Time frame: From enrollment to seven days after the surgery
Impact on the duration of hospitalisation
Duration of hospitalisation in days. Comparison of the preventive treatment bundle with the standard of care. Comparison of the posterior pericardial window alone compared to the standard of care. Comparison of the preventive treatment bundle compared to the posterior pericardial window alone.
Time frame: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of pericardial effusion requiring surgical correction during the hospitalization
Efficacy to decrease the incidence of pericardial effusion (requiring surgical correction) during hospitalization: * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone.
Time frame: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of the introduction of anticoagulants during hospitalization
Efficacy to decrease the number of patients for whom treatment with anticoagulants is necessary during hospitalization (in the case of a POAF episode of 48h or more or in case of POAF recurrence): * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone
Time frame: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of cardiac conduction disorders requiring temporary electro-training during hospitalization
Efficacy to reduce the occurrence of cardiac conduction disorders during hospitalization: * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone.
Time frame: From enrollment until end of hospitalisation (maximum of 3 years)
Cardiac health of patients at 1 year
General health state of patients as well as electrocardiogram and current treatments for cardiac disorders (based on data from standard follow-up by the patient's cardiologist) * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone
Time frame: At 1 year post-surgery
Cardiac health of patients at 3 years
General health state of patients as well as electrocardiogram and current treatments for cardiac disorders (based on data from standard follow-up by the patient's cardiologist) * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone
Time frame: At 3 years post-surgery
Incidence of gastrointestinal disorders
Time frame: From enrollment to the end of follow-up (maximum of 3 years)
Number of adverse reactions
Time frame: From enrollment to the end of follow-up (maximum of 3 years)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2029, 24 months later.
Of 56 non-industry phase 3 interventional studies under Atrial Fibrillation, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 73. This study's planned 24 months is below that.
Counting every sponsor, half of 76 studies reached it within 47 months; a quarter within 28 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Colchicine · Amiodarone
Elsan