Colchicine in Coronary Artery Bypass Graft (CABG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02122484
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : November 11, 2014
Evangelismos Hospital
Information provided by (Responsible Party):
Spyridon Deftereos, 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.

Condition or disease Intervention/treatment Phase
Elective Coronary Artery Bypass Graft Surgery Drug: Colchicine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control group
Patients taking placebo
Experimental: Colchicine
Active treatment group
Drug: Colchicine
colchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation

Primary Outcome Measures :
  1. Myocardial damage marker levels [ Time Frame: Days 1-2 post-CABG ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: At one and at six months after CABG ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02122484

Athens General Hospital "G. Gennimatas"
Athens, Attika, Greece, 11527
Sponsors and Collaborators
G.Gennimatas General Hospital
Evangelismos Hospital
Principal Investigator: Spyridon Deftereos, MD Athens General Hospital "G. Gennimatas"

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Spyridon Deftereos, Director, Cardiac Catheterization Department, G.Gennimatas General Hospital Identifier: NCT02122484     History of Changes
Other Study ID Numbers: COL.CABG
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014

Keywords provided by Spyridon Deftereos, G.Gennimatas General Hospital:
reperfusion damage

Additional relevant MeSH terms:
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents