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

ConditionsCoronary Artery DiseaseAtrial FibrillationCoronary Artery Bypass GraftingColchicine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTomsk Cardiology Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Elective coronary artery bypass grafting on pump;

signed informed consent to participate in the study.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • NSAID

    Drug

    standard CABG without performing pericardial fenestration intraoperatively

  • Colchicine 0.5 MG

    Drug

    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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of atrial fibrillation paroxysms (percent)

Differences between groups in the incidence of atrial fibrillation paroxysm development (percent)

Time frame
From the date of randomization until the date of discharge from hospital (from 10 days to 4 weeks)

Secondary outcomes

1

Incidence of pneumonia (percent)

Differences between groups in the incidence of pneumonia development (percent)

Time frame
From the date of randomization until the date of discharge from hospital (from 10 days to 4 weeks)
2

Incidence of mediastinitis (percent)

Differences between groups in the incidence of mediastinitis development (percent)

Time frame
From the date of randomization until the date of discharge from hospital (from 10 days to 4 weeks)
3

Level of C-reactive protein (CRP) (mg/L)

The difference in the levels of C-reactive protein (CRP) (mg/L) between the study groups after surgery

Time frame
10 days
4

Level of aspartate aminotransferase (AST) (U/L)

The difference in the levels of The difference in the levels of aspartate aminotransferase (AST) (U/L) between the study groups after surgery

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tomsk Cardiology Research Institute

Lead sponsor

Source ClinicalTrials.gov
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