Colchicine in Coronary Artery Bypass Graft (CABG)

NCT02122484 | Completed Phase 4 DMC

• 1 other identifier: COL.CABG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Coronary Artery Bypass Graft Surgery

Keywords

reperfusion damage

Outcome Measures

Primary Outcomes (1)

• Myocardial damage marker levels

  Days 1-2 post-CABG

Secondary Outcomes (1)

• All cause mortality

  At one and at six months after CABG

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients taking placebo

Colchicine

EXPERIMENTAL

Active treatment group

Drug: Colchicine

Interventions

Colchicine DRUG

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

Colchicine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery.

You may not qualify if:

• 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)

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead
• Evangelismos Hospital: collaborator

Study Sites (1)

Athens General Hospital "G. Gennimatas"

Athens, Attica, 11527, Greece

Location

Related Publications (1)

• Giannopoulos G, Angelidis C, Kouritas VK, Dedeilias P, Filippatos G, Cleman MW, Panagopoulou V, Siasos G, Tousoulis D, Lekakis J, Deftereos S. Usefulness of colchicine to reduce perioperative myocardial damage in patients who underwent on-pump coronary artery bypass grafting. Am J Cardiol. 2015 May 15;115(10):1376-81. doi: 10.1016/j.amjcard.2015.02.036. Epub 2015 Feb 18.

  PMID: 25784519 DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Spyridon Deftereos, MD

  Athens General Hospital "G. Gennimatas"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Catheterization Department

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

GR (1)