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

Study acronym: CAFE
StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 9 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06798714
Lead Sponsor Tomsk Cardiology Research Institute
Conditions
(from sponsor)		 Coronary Artery Disease, Atrial Fibrillation, Coronary Artery Bypass Grafting, Colchicine
Related terms Atrial Fibrillation, Coronary Artery Disease
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov