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

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

Sex: All

Ages: 18 Years – N/A

Phase: PHASE2

Enrollment: 100

Sponsor: University of Sao Paulo General Hospital

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.

Eligibility Criteria

Inclusion Criteria:Patients with acute coronary syndrome, with indication for myocardial revascularization surgeryPatients 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 therapyInflammatory 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05726019). StuddyBuddy aggregates publicly available trial information.