Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome (COCAR)

University of Sao Paulo General Hospital

Status and phase: Enrolling; Phase 2

Conditions: Postpericardiotomy Syndrome; Coronary Artery Disease; Myocardial Reperfusion; Acute Coronary Syndrome; Perioperative Myocardial Infarction; Postoperative Atrial Fibrilation; Coronary Artery Bypass

Treatments: Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05726019

SDC 5302/21/077

Details and patient eligibility

About

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.

Full description

Atherosclerotic disease and its consequences, such as cardiovascular and cerebrovascular disease, are the main causes of morbidity and mortality worldwide, with a rising prevalence as the age pyramid changes with the advancement of society's modernization and medical development. Despite advances, the risk of a new cardiovascular event persists in patients with acute coronary syndrome at around 20% in 3 years.

The search for intervention in the inflammatory pathway of atherosclerotic disease in acute coronary syndrome has been the subject of several studies in recent years. In particular, colchicine, a low-cost medication that acts on the inflammatory, atherosclerotic and arrhythmic process, has been the subject of studies in the setting of acute and chronic coronary syndrome and in the perioperative period of coronary artery bypass grafting.

In the elective perioperative context, it presents data that point to a reduction in myocardial injury and post-pericardiotomy syndrome. In addition to the pathophysiological therapeutic potential in postoperative atrial fibrillation, despite not having been demonstrated in a clinical study.

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.

The primary outcome will be a composite of postpericardiotomy syndrome, postoperative fibrillation, and periprocedural infarction. Secondary outcomes will be: (1) Death; (2) acute myocardial infarction; (3) stroke; (4) Readmission; (5) Post-pericardiotomy syndrome; (6) Postoperative atrial fibrillation; (7) Periprocedural infarction; (8) Infection; (9) myocardial injury; (10) Length of stay.

Evidences on the use of colchicine in the perioperative scenario of myocardial revascularization in patients with acute coronary syndrome are scarce, and the present study is a pioneer in this evaluation.

Objective documentation of the benefit of colchicine would imply the prescription of the current medication, with great potential for modifying the guidelines of specific medical societies.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute coronary syndrome, with indication for myocardial revascularization surgery
• Patients 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Colchicine

Active Comparator group

Description:

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.

Treatment:

Drug: Colchicine

Conventional treatment

No Intervention group

Description:

The control group will follow conventional treatment guided by current guidelines.