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
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