Colchicine in Coronary Artery Bypass Graft (CABG)

Phase 4

Completed

• Conditions: Elective Coronary Artery Bypass Graft Surgery
• Interventions: Drug: Colchicine

• Registration Number: NCT02122484
• Lead Sponsor: G.Gennimatas General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-24
• Primary Completion: 2014-06
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-08
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	Active treatment group

Primary Outcome Measures

Name	Time	Method
Myocardial damage marker levels	Days 1-2 post-CABG

Secondary Outcome Measures

Name	Time	Method
All cause mortality	At one and at six months after CABG

Trial Locations

Locations (1)

Athens General Hospital "G. Gennimatas"; 🇬🇷 Athens, Attika, Greece