Colchicine in Coronary Artery Bypass Graft (CABG) | NCT02122484

Studies
Colchicine in Coronary Artery Bypass Graft (CABG)

NCT02122484

Sponsor

G.Gennimatas General Hospital

Status

Completed

Last Update Posted

Nov 11, 2014Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Elective Coronary Artery Bypass Graft Surgery

Interventions

Colchicine

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Apr 22, 2014

First Submission Date that Met QC Criteria

Apr 23, 2014

First Posted Date

Apr 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Name	Class
Evangelismos Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Placebo Comparator	Patients taking placebo
Colchicine	Experimental	Active treatment group	Drug: Colchicine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colchicine	Drug	colchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation	Colchicine

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

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

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Spyridon Deftereos, MD	Athens General Hospital "G. Gennimatas"	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Athens General Hospital "G. Gennimatas"		Athens	Attica	11527	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25784519	Derived	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes

ID	Term
D000470	Alkaloids
D006571	Heterocyclic Compounds