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Colchicine in Coronary Artery Bypass Graft (CABG)

G

G.Gennimatas General Hospital

Status and phase

Completed
Phase 4

Conditions

Elective Coronary Artery Bypass Graft Surgery

Treatments

Drug: Colchicine

Study type

Interventional

Funder types

Other

Identifiers

NCT02122484
COL.CABG

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
Patients taking placebo
Colchicine
Experimental group
Description:
Active treatment group
Treatment:
Drug: Colchicine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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