NCT06798714CompletedPhase 4
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)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 13 Jan 2025
- Start date
- 20 Jan 2025
- Primary completion date
- 20 Jul 2025
- Lead sponsor
- Tomsk Cardiology Research Institute
- NCT number
- NCT06798714
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 140
- From 20 Jan 2025 to the primary completion date, 20 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously implanted pacemaker;
Other illness
- Valvular heart disease requiring surgical correction;
- Hypersensitivity to colchicine;
- History of alcoholism;
Lab values
- Reduced left ventricular ejection fraction (≤35%);
- Liver failure with an increase in liver transaminases ≥1.5 times;
- Renal failure (GFR\<35 mL/min/1.73 m2 calculated with CKD-EPI);
Other
- Permanent, persistent or paroxysmal atrial fibrillation;
- Neutropenia;
- Refusal to sign informed consent
Who the study is looking for
- Elective coronary artery bypass grafting on pump;
- signed informed consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.