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Completed

NCT Number: NCT02122484

Colchicine in Coronary Artery Bypass Graft (CABG)

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.

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Key information

Conditions

Elective Coronary Artery Bypass Graft Surgery Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Athens General Hospital "G. Gennimatas"

Athens, Attica, 11527, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Colchicine

Drug

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

Primary outcomes

  1. Myocardial damage marker levels

    Time frame: Days 1-2 post-CABG

Secondary outcomes

  1. All cause mortality

    Time frame: At one and at six months after CABG

Sponsors and collaborators

Lead sponsor

G.Gennimatas General Hospital

Other

Collaborators

  • Evangelismos Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2014
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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