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

NCT06798714 | Recruiting Phase 4

• 2 other identifiers: Tomsk Cardiology Research InstРег. № 123051500130-9:
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Atrial Fibrillation; Coronary Artery Bypass Grafting; Colchicine

Outcome Measures

Primary Outcomes (1)

• Incidence of atrial fibrillation paroxysms (percent)

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

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

Secondary Outcomes (9)

• Incidence of pneumonia (percent)

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

• Incidence of mediastinitis (percent)

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

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

  10 days

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

  10 days

• Level of alanine aminotransferase (ALT) (U/L)

  10 days

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard technique without performing the pericardial fenestration procedure intraoperatively. Standard postoperative treatment

Drug: NSAID

Experimental group

EXPERIMENTAL

Pericardial fenestration during coronary artery bypass grafting using the original technique. Colchicine (Colchicum-dispert) administration 4 hours before surgery and for 10 days after surgery

Drug: Colchicine 0.5 MG

Interventions

NSAID DRUG

standard CABG without performing pericardial fenestration intraoperatively

Also known as: non-steroidal anti-inflammatory drugs

Control group

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

Also known as: Colchicum-dispert

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk Cardiology Research Institute: lead

Study Sites (1)

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

Tomsk, 634012, Russia

RECRUITING

Related Publications (1)

• Diakova ML, Kuznetsov MS, Vechersky YY, Kim EB, Zyryanov SV, Petlin KA, Kozlov BN. A Combined Approach to the Prevention of Postoperative Atrial Fibrillation in Cardiac Surgery. Biomedicines. 2025 Aug 17;13(8):1999. doi: 10.3390/biomedicines13081999.

  PMID: 40868251 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Alkaloids; Heterocyclic Compounds

Study Officials

• Yuri Y Vechersky, PhD

  Cardiology Research Institute, Tomsk National Research Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariia L Diakova, PhD

CONTACT

+79039155049; prima.maria@mail.ru

Yuri Y Vechersky, PhD

CONTACT

+79039512225; vjj@cardio-tomsk.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1 (n=70): Patients who underwent pericardial fenestration during CABG surgery and received perioperative colchicine. Group 2 (n=70). Patients operated on using the standard technique (CABG without pericardial fenestration) and receiving NSAIDs in the postoperative period.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 29, 2025
• Study Start: January 20, 2025
• Primary Completion: July 20, 2025
• Study Completion: February 20, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-04

Locations

RU (1)