Coronary Artery DiseasePhase 4CAFENCT06798714
The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery
A Phase 4 study testing NSAID and Colchicine 0.5 MG in people with Coronary Artery Disease and Atrial Fibrillation, run by Tomsk Cardiology Research Institute at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation, Coronary Artery Bypass Grafting
- What is being tested?
- NSAID and Colchicine 0.5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jan 2025to 20 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective coronary artery bypass grafting on pump;
- signed informed consent to participate in the study.
Who cannot join
- 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;
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- Hypersensitivity to colchicine;
- Neutropenia;
- History of alcoholism;
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
Russia1 site
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia
Tomsk, 634012
About this study
Official title: The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery (CAFE)
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.
Read the detailed description
Study type: observational, analytical, cohort, prospective. Purpose: development of a new comprehensive method for perioperative prevention of atrial fibrillation paroxysms in cardiac surgery patients at the hospital stage.
Objectives:
- To assess the risk factors that influence the development of atrial fibrillation in the early postoperative period;
- To conduct a comparative analysis of various therapy methods to reduce the risk of developing atrial fibrillation paroxysms in the early postoperative period in cardiac surgery patients.
To solve the set tasks, it is planned to conduct a cohort prospective observational study of patients with coronary artery disease who underwent coronary artery bypass grafting with cardiopulmonary bypass.
Duration of the study - 1,5 years. The observation period for patients is the hospital postoperative period after CABG.
The study is planned to include 140 patients diagnosed with coronary heart disease. The diagnosis will be established on the basis of medical records and coronary angiography. Indications for CABG surgery will be determined by a consulting cardiac surgeon in accordance with the current Clinical Guidelines of the Ministry of Health of the Russian Federation "Stable ischemic heart disease" (2020).
Patients should be over 18 years old. It is planned to recruit 70 patients who will undergo pericardial fenestration during coronary artery bypass grafting using the original technique (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. Diclofenac will be used as an NSAID in the postoperative period at a daily dose of 100 mg (orally). Colchicine (trade name of the drug "Colchicum-dispert") 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. Since the drug is not registered for the prevention of atrial fibrillation in the postoperative period, its prescription will be decided by a council of doctors, including at least 3 people (head of the department, attending physician, and research physician).
Safety evaluation Since no medical studies or interventions will be carried out in addition to what the patient should receive during standard examination and treatment, participation in this study does not entail any risks and threats to the patient.
The safety endpoints of standard treatment for this disease will be analyzed. Statistical analysis Statistical analysis of data will be carried out in the STATISTICA 10 StatSoft program. Inc. 1984-2011 (USA). Quantitative values will be displayed as median and quartiles Me [25;75]. Comparison of quantitative characteristics between groups will be performed using the Mann-Whitney U-test. Fisher's exact test will be used to compare qualitative characteristics. Differences will be considered statistically significant at p < 0.05.
Ethical and legal issues of the study:
The study was approved by the Biomedical Ethics Committee at Cardiology Research Institute of Tomsk National Research Medical Center.
All patients must sign an informed consent form allowing the use of information about their examination and treatment for scientific purposes with subsequent publication of materials in the open press. The study will be conducted in accordance with the current version of the Declaration of Helsinki, the provisions of the National Standard of the Russian Federation GOST R52379-2005 on Good Clinical Practice dated April 1, 2006, the Order of the Ministry of Health of the Russian Federation dated April 1, 2016 No. 200n "On approval of the rules of good clinical practice" and the provisions of Good Clinical Practice (GCP).
The procedure for informing study subjects and obtaining written consent from them will be carried out in accordance with GCP standards.
- Being tested
- NSAID, Colchicine 0.5 MG
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDDrug
Also called non-steroidal anti-inflammatory drugs
standard CABG without performing pericardial fenestration intraoperatively
Colchicine 0.5 MGDrug
Also called Colchicum-dispert
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard technique without performing the pericardial fenestration procedure intraoperatively. Standard postoperative treatment Receives: 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 Receives: Drug: Colchicine 0.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial fibrillation paroxysms (percent)
Differences between groups in the incidence of atrial fibrillation paroxysm development (percent)
Measured: 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)
Differences between groups in the incidence of pneumonia development (percent)
Measured: From the date of randomization until the date of discharge from hospital (from 10 days to 4 weeks)
Incidence of mediastinitis (percent)
Differences between groups in the incidence of mediastinitis development (percent)
Measured: 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)
The difference in the levels of C-reactive protein (CRP) (mg/L) between the study groups after surgery
Measured: 10 days
Level of aspartate aminotransferase (AST) (U/L)
The difference in the levels of The difference in the levels of aspartate aminotransferase (AST) (U/L) between the study groups after surgery
Measured: 10 days
Level of alanine aminotransferase (ALT) (U/L)
The difference in the levels of The difference in the levels of alanine aminotransferase (ALT) (U/L) between the study groups after surgery
Measured: 10 days
Level of blood creatinine (µmol/L)
The difference in the levels of blood creatinine (µmol/L) between the study groups after surgery
Measured: 10 days
Pericardial fluid volume (mL)
The difference in the volume of pericardial fluid (mL) between the study groups after surgery
Measured: 10 days
Pleural fluid volume (mL)
The difference in the volume of pleural fluid (mL) between the study groups after surgery
Measured: 10 days
Incidence of gastrointestinal disorders (percent)
Differences between groups in the incidence of nausea and/or diarrhea after surgery
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start20 Jan 2025
- Primary completion20 Jul 2025
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk Cardiology Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuri Y Vechersky, PhD, Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798714
- Sponsor's protocol ID
- Tomsk Cardiology Research Inst
- Other IDs
- Рег. № 123051500130-9:
- Acronym
- CAFE
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40868251
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery (CAFE)
- ClinicalTrials.gov ID
- NCT06798714
- Acronym / sponsor ID
- CAFE / Tomsk Cardiology Research Inst
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Tomsk Cardiology Research InstituteUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study type: observational, analytical, cohort, prospective. Purpose: development of a new comprehensive method for perioperative prevention of atrial fibrillation paroxysms in cardiac surgery patients at the hospital stage.
Objectives:
- To assess the risk factors that influence the development of atrial fibrillation in the early postoperative period;
- To conduct a comparative analysis of various therapy methods to reduce the risk of developing atrial fibrillation paroxysms in the early postoperative period in cardiac surgery patients.
To solve the set tasks, it is planned to conduct a cohort prospective observational study of patients with coronary artery disease who underwent coronary artery bypass grafting with cardiopulmonary bypass.
Duration of the study - 1,5 years. The observation period for patients is the hospital postoperative period after CABG.
The study is planned to include 140 patients diagnosed with coronary heart disease. The diagnosis will be established on the basis of medical records and coronary angiography. Indications for CABG surgery will be determined by a consulting cardiac surgeon in accordance with the current Clinical Guidelines of the Ministry of Health of the Russian Federation "Stable ischemic heart disease" (2020).
Patients should be over 18 years old. It is planned to recruit 70 patients who will undergo pericardial fenestration during coronary artery bypass grafting using the original technique (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. Diclofenac will be used as an NSAID in the postoperative period at a daily dose of 100 mg (orally). Colchicine (trade name of the drug "Colchicum-dispert") 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. Since the drug is not registered for the prevention of atrial fibrillation in the postoperative period, its prescription will be decided by a council of doctors, including at least 3 people (head of the department, attending physician, and research physician).
Safety evaluation Since no medical studies or interventions will be carried out in addition to what the patient should receive during standard examination and treatment, participation in this study does not entail any risks and threats to the patient.
The safety endpoints of standard treatment for this disease will be analyzed. Statistical analysis Statistical analysis of data will be carried out in the STATISTICA 10 StatSoft program. Inc. 1984-2011 (USA). Quantitative values will be displayed as median and quartiles Me [25;75]. Comparison of quantitative characteristics between groups will be performed using the Mann-Whitney U-test. Fisher's exact test will be used to compare qualitative characteristics. Differences will be considered statistically significant at p < 0.05.
Ethical and legal issues of the study:
The study was approved by the Biomedical Ethics Committee at Cardiology Research Institute of Tomsk National Research Medical Center.
All patients must sign an informed consent form allowing the use of information about their examination and treatment for scientific purposes with subsequent publication of materials in the open press. The study will be conducted in accordance with the current version of the Declaration of Helsinki, the provisions of the National Standard of the Russian Federation GOST R52379-2005 on Good Clinical Practice dated April 1, 2006, the Order of the Ministry of Health of the Russian Federation dated April 1, 2016 No. 200n "On approval of the rules of good clinical practice" and the provisions of Good Clinical Practice (GCP).
The procedure for informing study subjects and obtaining written consent from them will be carried out in accordance with GCP standards.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: NSAIDStandard technique without performing the pericardial fenestration procedure intraoperatively. Standard postoperative treatment |
| Experimental group | Experimental | Drug: Colchicine 0.5 MGPericardial fenestration during coronary artery bypass grafting using the original technique. Colchicine (Colchicum-dispert) administration 4 hours before surgery and for 10 days after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective coronary artery bypass grafting on pump;
- signed informed consent to participate in the study.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSAIDAlso: non-steroidal anti-inflammatory drugsstandard CABG without performing pericardial fenestration intraoperatively | Drug | Control group |
| Colchicine 0.5 MGAlso: Colchicum-dispertColchicine 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 | Drug | Experimental group |
Primary outcome
Incidence of atrial fibrillation paroxysms (percent)
Time frame: From the date of randomization until the date of discharge from hospital (from 10 days to 4 weeks)
Differences between groups in the incidence of atrial fibrillation paroxysm development (percent)
9 secondary outcomes
Incidence of pneumonia (percent)
Time frame: From the date of randomization until the date of discharge from hospital (from 10 days to 4 weeks)
Incidence of mediastinitis (percent)
Time frame: 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)
Time frame: 10 days
Level of aspartate aminotransferase (AST) (U/L)
Time frame: 10 days
Level of alanine aminotransferase (ALT) (U/L)
Time frame: 10 days
Level of blood creatinine (µmol/L)
Time frame: 10 days
Pericardial fluid volume (mL)
Time frame: 10 days
Pleural fluid volume (mL)
Time frame: 10 days
Incidence of gastrointestinal disorders (percent)
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 40868251Diakova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuri Y Vechersky, PhD principal investigator
Cardiology Research Institute, Tomsk National Research Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NSAID and Colchicine 0.5 MG in people with Coronary Artery Disease and Atrial Fibrillation, run by Tomsk Cardiology Research Institute at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atrial fibrillation paroxysms (percent) (time frame: From the date of randomization until the date of discharge from hospital (from 10 days to 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06798714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.