NCT06798714 The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery
| NCT ID | NCT06798714 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tomsk Cardiology Research Institute |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2025-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2025-01-20 with a primary completion date of 2025-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Elective coronary artery bypass grafting on pump; 2. signed informed consent to participate in the study. Exclusion Criteria: 1. Reduced left ventricular ejection fraction (≤35%); 2. Valvular heart disease requiring surgical correction; 3. Liver failure with an increase in liver transaminases ≥1.5 times; 4. Renal failure (GFR\<35 mL/min/1.73 m2 calculated with CKD-EPI); 5. Permanent, persistent or paroxysmal atrial fibrillation; 6. Previously implanted pacemaker; 7. Hypersensitivity to colchicine; 8. Neutropenia; 9. History of alcoholism; 10. Refusal to sign informed consent
Contact & Investigator
Yuri Y Vechersky, PhD
PRINCIPAL INVESTIGATOR
Cardiology Research Institute, Tomsk National Research Medical Center
Frequently Asked Questions
Who can join the NCT06798714 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06798714 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06798714 currently recruiting?
Yes, NCT06798714 is actively recruiting participants. Contact the research team at prima.maria@mail.ru for enrollment information.
Where is the NCT06798714 trial being conducted?
This trial is being conducted at Tomsk, Russia.
Who is sponsoring the NCT06798714 clinical trial?
NCT06798714 is sponsored by Tomsk Cardiology Research Institute. The principal investigator is Yuri Y Vechersky, PhD at Cardiology Research Institute, Tomsk National Research Medical Center. The trial plans to enroll 140 participants.