RecruitingPhase 4NCT06798714

The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery

The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery (CAFE)

Sponsor

Tomsk Cardiology Research Institute

Enrollment

140 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Coronary Artery Disease Coronary Artery Bypass Grafting Colchicine

Summary

Development of a new comprehensive method for perioperative prevention of atrial fibrillation paroxysms in cardiac surgery patients at the hospital stage. It is planned to recruit 70 patients who will undergo pericardial fenestration during the operation using the original technique during coronary artery bypass grafting (Patent No. 2647626 C1 Russian Federation), and will be prescribed colchicine (the drug "Colchicum-dispert") in the perioperative period in order to prevent the development of paroxysms of atrial fibrillation in the postoperative period, and 70 cardiac surgery patients operated on using the standard technique (without performing the pericardial fenestration procedure intraoperatively), receiving non-steroidal anti-inflammatory drugs in the postoperative period.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether colchicine — an inexpensive anti-inflammatory drug commonly used for gout — can reduce the chance of developing atrial fibrillation (an irregular, fast heartbeat) after coronary artery bypass graft (CABG) surgery. Post-operative atrial fibrillation is one of the most common complications after heart surgery. **You may be eligible if...** - You are scheduled for elective coronary artery bypass graft (CABG) surgery using a heart-lung bypass machine - You consent to participate in the study **You may NOT be eligible if...** - Your heart's pumping function is severely reduced (ejection fraction of 35% or less) - You need valve repair or replacement surgery at the same time - You have significant liver or kidney problems - You already have atrial fibrillation (permanent, persistent, or paroxysmal) - You have a pacemaker - You have an allergy to colchicine, low white blood cell counts, or a history of alcoholism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNSAID

standard CABG without performing pericardial fenestration intraoperatively

DRUGColchicine 0.5 MG

Colchicine will be prescribed in a dose of 500 micrograms 4 hours before surgery and 500 micrograms 2 times a day for 10 days after surgery with pericardial fenestration

Locations(1)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia

Tomsk, Russia

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NCT06798714

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