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Colchicine in Coronary Artery Bypass Graft (CABG)

NCT ID: NCT02122484

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Elective Coronary Artery Bypass Graft Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Patients taking placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Colchicine

Active treatment group

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

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

Interventions

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Colchicine

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evangelismos Hospital

OTHER

Sponsor Role collaborator

G.Gennimatas General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Spyridon Deftereos

Director, Cardiac Catheterization Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Spyridon Deftereos, MD

Role: PRINCIPAL_INVESTIGATOR

Athens General Hospital "G. Gennimatas"

Locations

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Athens General Hospital "G. Gennimatas"

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 25784519 (View on PubMed)

Other Identifiers

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COL.CABG

Identifier Type: -

Identifier Source: org_study_id