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Colchicine in Coronary Artery Bypass Graft (CABG)

Information source: G.Gennimatas General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Elective Coronary Artery Bypass Graft Surgery

Intervention: Colchicine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: G.Gennimatas General Hospital

Official(s) and/or principal investigator(s):
Spyridon Deftereos, MD, Principal Investigator, Affiliation: Athens General Hospital "G. Gennimatas"

Summary

There 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.

Clinical Details

Official title: Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Myocardial damage marker levels

Secondary outcome: All cause mortality

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Athens General Hospital "G. Gennimatas", Athens, Attika 11527, Greece
Additional Information

Starting date: November 2013
Last updated: November 8, 2014

Page last updated: August 20, 2015

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