CompletedPhase 2

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

Brazil100 participantsStarted 2022-02-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: 30 days after coronary artery bypass graft

Trial details

NCT IDNCT05726019

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-21

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