Elective Coronary Artery Bypass Graft SurgeryPhase 4NCT02122484
Colchicine in Coronary Artery Bypass Graft (CABG)
A Phase 4 study testing Colchicine in people with Elective Coronary Artery Bypass Graft Surgery, run by G.Gennimatas General Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elective Coronary Artery Bypass Graft Surgery
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2013to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Colchicine
- Keywords
- reperfusion damage
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
colchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients taking placebo |
| Colchicine | Experimental | Active treatment group Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial damage marker levels
Measured: Days 1-2 post-CABG
Secondary outcomes (1)
All cause mortality
Measured: At one and at six months after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Evangelismos Hospital
- Responsible party
- Principal investigator, Spyridon Deftereos, G.Gennimatas General Hospital
- Investigators
- Spyridon Deftereos, MD, Principal investigator, Athens General Hospital "G. Gennimatas"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122484
- Sponsor's protocol ID
- COL.CABG
- Status last verified
- Nov 2014
- First submitted
- 22 Apr 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25784519
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage
- ClinicalTrials.gov ID
- NCT02122484
- Acronym / sponsor ID
- COL.CABG
- Keywords
- reperfusion damage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Collaborators
- Evangelismos Hospital
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | –Patients taking placebo |
| Colchicine | Experimental | Drug: ColchicineActive treatment group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicinecolchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation | Drug | Colchicine |
Primary outcome
Myocardial damage marker levels
Time frame: Days 1-2 post-CABG
1 secondary outcome
All cause mortality
Time frame: At one and at six months after CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
- Derived from this study: PubMed 25784519Giannopoulos 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spyridon Deftereos, MD principal investigator
Athens General Hospital "G. Gennimatas"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine in people with Elective Coronary Artery Bypass Graft Surgery, run by G.Gennimatas General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial damage marker levels (time frame: Days 1-2 post-CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02122484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.