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

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

Inclusion Criteria2

  • Elective coronary artery bypass grafting on pump;
  • signed informed consent to participate in the study.

Exclusion Criteria10

  • Reduced left ventricular ejection fraction (≤35%);
  • Valvular heart disease requiring surgical correction;
  • Liver failure with an increase in liver transaminases ≥1.5 times;
  • Renal failure (GFR\<35 mL/min/1.73 m2 calculated with CKD-EPI);
  • Permanent, persistent or paroxysmal atrial fibrillation;
  • Previously implanted pacemaker;
  • Hypersensitivity to colchicine;
  • Neutropenia;
  • History of alcoholism;
  • Refusal to sign informed consent

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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