Title
Colchicine in Coronary Artery Bypass Graft (CABG)
Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage
Phase
Phase 4Lead Sponsor
Gennimatas Hospital, AthensStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Elective Coronary Artery Bypass Graft SurgeryIntervention/Treatment
colchicine ...Study Participants
60There is evidence that inflammatory processes may play a key role during surgical myocardial reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may lead to reduction in periprocedural infarct size, when administered during elective coronary artery bypass graft surgery.
colchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation
Patients taking placebo
Inclusion Criteria: The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery. Exclusion Criteria: Excluded are patients: with age > 80 years old scheduled for concomitant valve surgery scheduled for coronary surgery without cardiopulmonary bypass with peripheral vascular disease affecting the upper limbs with acute coronary syndrome within the previous 4 weeks on inotropic or mechanical circulatory support before induction of anaesthesia with any disorder that could potentially increase preoperative cTnI concentrations (eg, percutaneous coronary intervention within the previous 6 weeks) with active inflammatory diseases, infectious diseases or known malignancy under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents with known hypersensitivity-allergy to colchicine under chronic treatment with colchicine with severe renal failure (eGFR < 35 ml/min/1.73 m2) with hepatic failure (Child - Pugh class B or C)
