Colchicine in Coronary Artery Bypass Graft (CABG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Evangelismos Hospital
Information provided by (Responsible Party):
Spyridon Deftereos, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier:
NCT02122484
First received: April 22, 2014
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Elective Coronary Artery Bypass Graft Surgery
Drug: Colchicine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage

Resource links provided by NLM:


Further study details as provided by G.Gennimatas General Hospital:

Primary Outcome Measures:
  • Myocardial damage marker levels [ Time Frame: Days 1-2 post-CABG ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: At one and at six months after CABG ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02122484

Locations
Greece
Athens General Hospital "G. Gennimatas"
Athens, Attika, Greece, 11527
Sponsors and Collaborators
G.Gennimatas General Hospital
Evangelismos Hospital
Investigators
Principal Investigator: Spyridon Deftereos, MD Athens General Hospital "G. Gennimatas"
  More Information

No publications provided

Responsible Party: Spyridon Deftereos, Director, Cardiac Catheterization Department, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier: NCT02122484     History of Changes
Other Study ID Numbers: COL.CABG
Study First Received: April 22, 2014
Last Updated: August 20, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by G.Gennimatas General Hospital:
reperfusion damage

Additional relevant MeSH terms:
Colchicine
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014