Colchicine in Coronary Artery Bypass Graft (CABG)

November 8, 2014 updated by: Spyridon Deftereos, G.Gennimatas General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attika
      • Athens, Attika, Greece, 11527
        • Athens General Hospital "G. Gennimatas"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial damage marker levels
Time Frame: Days 1-2 post-CABG
Days 1-2 post-CABG

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: At one and at six months after CABG
At one and at six months after CABG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G.Gennimatas General Hospital

Collaborators

Evangelismos Hospital

Investigators

  • Principal Investigator: Spyridon Deftereos, MD, Athens General Hospital "G. Gennimatas"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (ESTIMATE)

April 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 8, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL.CABG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Elective Coronary Artery Bypass Graft Surgery

Clinical Trials on Colchicine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe