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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02122484

Enrollment

Registered

2014-04-24

Start date

2013-11-30

Completion date

2014-11-30

Last updated

2014-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Coronary Artery Bypass Graft Surgery

Keywords

reperfusion damage

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.

Interventions

DRUGColchicine

colchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Myocardial damage marker levels	Days 1-2 post-CABG

Secondary

Measure	Time frame
All cause mortality	At one and at six months after CABG

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026