Coronary Artery DiseasePhase 2COCARNCT05726019
Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome
A Phase 2 study testing Colchicine in people with Coronary Artery Disease and Acute Coronary Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The present study seeks to evaluate the effectiveness of the use of perioperative colchicine with regard to operative complications, in patients with acute coronary syndrome and indication for cardiac post-surgical revascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome, Coronary Artery Bypass
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Feb 2022to 21 Dec 2025
- Phase
- Phase 2
- 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
- Patients with acute coronary syndrome, with indication for myocardial revascularization surgery
- Patients of both genders, aged over 18 years.
Who cannot join
- Inability to sign the informed consent form;
- Current use of colchicine;
- Current use of long-term corticosteroid therapy
- Inflammatory bowel disease or chronic diarrhea;
- Clinically significant non-transient haematological abnormalities;
- Renal dysfunction, with creatinine greater than 2 times the upper limit of normality;
Show all 9Show fewer
- Severe liver disease;
- Drug addiction or alcoholism;
- History of clinically significant sensitivity to colchicine.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute - University of São Paulo
São Paulo, São Paulo, 05403000
About this study
Official title: Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome: an Open-label Randomized Trial
The present study seeks to evaluate the effectiveness of the use of perioperative colchicine with regard to operative complications, in patients with acute coronary syndrome and indication for cardiac post-surgical revascularization.
Patients will be selected and randomized while still in the emergency room and medication (colchicine 0.5mg every 12 hours or placebo) will be started within 24 hours of randomization, being maintained for 30 days after surgery.
Read the detailed description
Atherosclerotic cardiovascular disease remains a leading cause of global morbidity and mortality. Despite advances in medical therapy, patients presenting with Acute Coronary Syndrome (ACS) sustain a high residual risk of recurrent events, largely driven by inflammatory pathways.
Consequently, targeting inflammation has become a major focus of recent cardiovascular research. Colchicine, a widely available and low-cost anti-inflammatory agent, has demonstrated significant benefits in both acute and chronic coronary syndromes. In the setting of elective coronary artery bypass grafting (CABG), prophylactic colchicine has been shown to reduce perioperative myocardial injury and the incidence of post-pericardiotomy syndrome, with a strong pathophysiological rationale for preventing postoperative atrial fibrillation (POAF).
However, evidence regarding the use of perioperative colchicine in the highly vulnerable scenario of patients presenting with ACS who require surgical revascularization (a "double inflammatory hit" model) is scarce. The present study seeks to evaluate the effectiveness of perioperative colchicine in preventing major operative complications in this specific high-risk ACS population. Objective documentation of the benefit of colchicine in this setting could pioneer a new therapeutic approach with great potential to modify current medical guidelines.
To address this gap, the trial utilizes a Prospective Randomized Open-label Blinded Endpoint (PROBE) design. While the allocation to the intervention (colchicine) or standard of care is open-label to both patients and the clinical care team, the assessment of all clinical endpoints is strictly masked.
To mitigate detection and observer bias, an independent Clinical Events Committee (CEC) was established. This committee is composed of physicians who are not involved in patient recruitment or direct clinical care. The CEC performs the formal, blinded adjudication of all clinical efficacy and safety events. The adjudication process is conducted using raw, anonymized clinical data (ECGs, cardiac biomarkers, surgical reports, and imaging), with the committee completely blinded to the randomized treatment allocation.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Coronary Artery Bypass, Myocardial Reperfusion, Postpericardiotomy Syndrome, Postoperative Atrial Fibrilation
- Being tested
- Colchicine
- Keywords
- Colchicine, Acute Coronary Syndrome, Coronary Artery Bypass, Myocardial Reperfusion, Postpericardiotomy Syndrome, Postoperative atrial fibrilation, Perioperative Myocardial Infarction, Coronary Artery Disease, Atherosclerosis, Cardiac Surgery, Cardiology
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Postpericardiotomy Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Oral tablet colchicine 0.5mg, twice a day, will be started within 24 hours after randomization and maintained until 30 days after coronary artery bypass grafting.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | Oral tablet colchicine 0.5mg, twice a day, will be started within 24 hours after randomization and maintained until 30 days after coronary artery bypass grafting. Receives: Drug: Colchicine |
| Conventional treatment | No intervention | The control group will follow conventional treatment guided by current guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of postpericardiotomy syndrome, postoperative fibrillation, and periprocedural myocardial infarction.
Measured: 30 days after coronary artery bypass graft
Secondary outcomes (10)
Death
Measured: 30 days after coronary artery bypass graft
Myocardial infarction
Measured: 30 days after coronary artery bypass graft
Stroke
Measured: 30 days after coronary artery bypass graft
Hospital readmission
Measured: 30 days after coronary artery bypass graft
Postpericardiotomy syndrome
Measured: 30 days after coronary artery bypass graft
Postoperative fibrillation
Measured: 30 days after coronary artery bypass graft
Periprocedural myocardial infarction
Measured: 30 days after coronary artery bypass graft
Infection
Infection of any kind
Measured: 30 days after coronary artery bypass graft
Myocardial injury
Measured: 30 days after coronary artery bypass graft
Length of stay
Measured: 30 days after coronary artery bypass graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start5 Feb 2022
- Primary completion21 Dec 2025
- Study completion21 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, open-label, randomized study. Patients with acute coronary syndrome, who meet criteria for surgical myocardial revascularization, will be selected and randomize, with drug addition, in the intervention group, within a maximum of 24 hours after randomization and maintained for up to 30 days after coronary artery bypass grafting. Inclusion criteria: Individuals with acute coronary syndrome, with indication for myocardial revascularization surgery, of both genders, aged over 18 years. Exclusion criteria: Inability to sign the informed consent form; Current use of colchicine; Current use of long-term corticosteroid therapy; Inflammatory bowel disease or chronic diarrhea; Clinically significant non-transient haematological abnormalities; Renal dysfunction, with creatinine greater than 2 times the upper limit of normality; Severe liver disease; Drug addiction or alcoholism; History of clinically significant sensitivity to colchicine.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726019
- Sponsor's protocol ID
- SDC 5302/21/077
- Acronym
- COCAR
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome: an Open-label Randomized Trial
- ClinicalTrials.gov ID
- NCT05726019
- Acronym / sponsor ID
- COCAR / SDC 5302/21/077
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Coronary Artery Bypass, Myocardial Reperfusion, Postpericardiotomy Syndrome, Postoperative Atrial Fibrilation
- Keywords
- Colchicine, Acute Coronary Syndrome, Coronary Artery Bypass, Myocardial Reperfusion, Postpericardiotomy Syndrome, Postoperative atrial fibrilation, Perioperative Myocardial Infarction, Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 21 Dec 2025 (actual)
- First posted
- 13 Feb 2023 (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.
The present study seeks to evaluate the effectiveness of the use of perioperative colchicine with regard to operative complications, in patients with acute coronary syndrome and indication for cardiac post-surgical revascularization.
Patients will be selected and randomized while still in the emergency room and medication (colchicine 0.5mg every 12 hours or placebo) will be started within 24 hours of randomization, being maintained for 30 days after surgery.
Detailed description
Atherosclerotic cardiovascular disease remains a leading cause of global morbidity and mortality. Despite advances in medical therapy, patients presenting with Acute Coronary Syndrome (ACS) sustain a high residual risk of recurrent events, largely driven by inflammatory pathways.
Consequently, targeting inflammation has become a major focus of recent cardiovascular research. Colchicine, a widely available and low-cost anti-inflammatory agent, has demonstrated significant benefits in both acute and chronic coronary syndromes. In the setting of elective coronary artery bypass grafting (CABG), prophylactic colchicine has been shown to reduce perioperative myocardial injury and the incidence of post-pericardiotomy syndrome, with a strong pathophysiological rationale for preventing postoperative atrial fibrillation (POAF).
However, evidence regarding the use of perioperative colchicine in the highly vulnerable scenario of patients presenting with ACS who require surgical revascularization (a "double inflammatory hit" model) is scarce. The present study seeks to evaluate the effectiveness of perioperative colchicine in preventing major operative complications in this specific high-risk ACS population. Objective documentation of the benefit of colchicine in this setting could pioneer a new therapeutic approach with great potential to modify current medical guidelines.
To address this gap, the trial utilizes a Prospective Randomized Open-label Blinded Endpoint (PROBE) design. While the allocation to the intervention (colchicine) or standard of care is open-label to both patients and the clinical care team, the assessment of all clinical endpoints is strictly masked.
To mitigate detection and observer bias, an independent Clinical Events Committee (CEC) was established. This committee is composed of physicians who are not involved in patient recruitment or direct clinical care. The CEC performs the formal, blinded adjudication of all clinical efficacy and safety events. The adjudication process is conducted using raw, anonymized clinical data (ECGs, cardiac biomarkers, surgical reports, and imaging), with the committee completely blinded to the randomized treatment allocation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, prospective, open-label, randomized study. Patients with acute coronary syndrome, who meet criteria for surgical myocardial revascularization, will be selected and randomize, with drug addition, in the intervention group, within a maximum of 24 hours after randomization and maintained for up to 30 days after coronary artery bypass grafting. Inclusion criteria: Individuals with acute coronary syndrome, with indication for myocardial revascularization surgery, of both genders, aged over 18 years. Exclusion criteria: Inability to sign the informed consent form; Current use of colchicine; Current use of long-term corticosteroid therapy; Inflammatory bowel disease or chronic diarrhea; Clinically significant non-transient haematological abnormalities; Renal dysfunction, with creatinine greater than 2 times the upper limit of normality; Severe liver disease; Drug addiction or alcoholism; History of clinically significant sensitivity to colchicine.
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: ColchicineOral tablet colchicine 0.5mg, twice a day, will be started within 24 hours after randomization and maintained until 30 days after coronary artery bypass grafting. |
| Conventional treatment | No intervention | –The control group will follow conventional treatment guided by current guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with acute coronary syndrome, with indication for myocardial revascularization surgery
- Patients of both genders, aged over 18 years.
Key exclusion criteria (9 listed)
- Inability to sign the informed consent form;
- Current use of colchicine;
- Current use of long-term corticosteroid therapy
- Inflammatory bowel disease or chronic diarrhea;
- Clinically significant non-transient haematological abnormalities;
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 |
|---|---|---|
| ColchicineOral tablet colchicine 0.5mg, twice a day, will be started within 24 hours after randomization and maintained until 30 days after coronary artery bypass grafting. | Drug | Colchicine |
Primary outcome
Composite outcome of postpericardiotomy syndrome, postoperative fibrillation, and periprocedural myocardial infarction.
Time frame: 30 days after coronary artery bypass graft
10 secondary outcomes
Death
Time frame: 30 days after coronary artery bypass graft
Myocardial infarction
Time frame: 30 days after coronary artery bypass graft
Stroke
Time frame: 30 days after coronary artery bypass graft
Hospital readmission
Time frame: 30 days after coronary artery bypass graft
Postpericardiotomy syndrome
Time frame: 30 days after coronary artery bypass graft
Postoperative fibrillation
Time frame: 30 days after coronary artery bypass graft
Periprocedural myocardial infarction
Time frame: 30 days after coronary artery bypass graft
Infection
Time frame: 30 days after coronary artery bypass graft
Myocardial injury
Time frame: 30 days after coronary artery bypass graft
Length of stay
Time frame: 30 days after coronary artery bypass graft
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 3 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Coronary Artery Disease and Acute Coronary Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 9 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 3 Mar 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Composite outcome of postpericardiotomy syndrome, postoperative fibrillation, and periprocedural myocardial infarction. (time frame: 30 days after coronary artery bypass graft). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.