Colchicine's effect on preventing atrial fibrillation after heart surgery
The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery (CAFE)
This study tests whether colchicine can help prevent atrial fibrillation in patients recovering from heart surgery compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tomsk Cardiology Research Institute Academic / other |
| Locations | 1 site (Tomsk) |
| Trial ID | NCT06798714 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of colchicine to prevent atrial fibrillation in patients undergoing coronary artery bypass grafting (CABG). It will compare outcomes between patients receiving colchicine and those receiving standard postoperative care. The study aims to identify risk factors for atrial fibrillation and evaluate the effectiveness of different therapeutic approaches. A total of 140 patients will be observed during their hospital stay following surgery, with a focus on the early postoperative period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for elective coronary artery bypass grafting.
Not a fit: Patients with severe heart or kidney conditions, or those with a history of atrial fibrillation, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of atrial fibrillation in cardiac surgery patients, improving recovery outcomes.
How similar studies have performed: Previous studies have shown promising results with colchicine in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tomsk
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia — Tomsk, Russia (Recruiting)
Study contacts
- Principal investigator: Yuri Y Vechersky, PhD — Cardiology Research Institute, Tomsk National Research Medical Center
- Study coordinator: Mariia L Diakova, PhD
- Email: prima.maria@mail.ru
- Phone: +79039155049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.