Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome

NCT05726019 | Completed Phase 2

• 1 other identifier: SDC 5302/21/077
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Composite outcome of postpericardiotomy syndrome, postoperative fibrillation, and periprocedural myocardial infarction.

  30 days after coronary artery bypass graft

Secondary Outcomes (10)

• Death

  30 days after coronary artery bypass graft

• Myocardial infarction

  30 days after coronary artery bypass graft

• Stroke

  30 days after coronary artery bypass graft

• Hospital readmission

  30 days after coronary artery bypass graft

• Postpericardiotomy syndrome

  30 days after coronary artery bypass graft

Study Arms (2)

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.

Drug: Colchicine

Conventional treatment

NO INTERVENTION

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

Interventions

Colchicine DRUG

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.

Colchicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute coronary syndrome, with indication for myocardial revascularization surgery
• Patients of both genders, aged over 18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Heart Institute - University of São Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Postpericardiotomy Syndrome; Atherosclerosis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: February 5, 2022
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

BR (1)