Colchicine in ST-elevation Myocardial Infarction

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by G.Gennimatas General Hospital
Information provided by (Responsible Party):
Spyridon Deftereos, G.Gennimatas General Hospital Identifier:
First received: September 2, 2013
Last updated: April 22, 2015
Last verified: April 2015
  • There is evidence that inflammatory processes may play detrimental role during the acute phase of myocardial infarction
  • The hypothesis of this study is that colchicine, by its anti-inflammatory action, may lead to reduction in infarct size, when administered during the acute phase of myocardial infarction

Condition Intervention Phase
Acute Myocardial Infarction
Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
Drug: Placebo
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 the Acute Phase of ST-elevation Myocardial Infarction to Reduce Infarct Size

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Infarct size on MRI [ Time Frame: 5 days post-MI ] [ Designated as safety issue: No ]
    MRI with LGE will be performed in a subset of study participants

  • AUC CK-MB concentration [ Time Frame: 0-3 days post-MI ] [ Designated as safety issue: No ]
    Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits

Secondary Outcome Measures:
  • Myocardial damage marker levels [ Time Frame: Days 1-3 post-MI ] [ Designated as safety issue: No ]
    Maximal concentrations of hs-TnT and CK-MB

Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
Patients taking placebo
Drug: Placebo
Experimental: Colchicine
Active treatment group
Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days


Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The study will enroll patients 18 years old or older who present to the hospital within twelve (12) hours of the onset of chest pain and who had ST segment elevation >1 mm in two contiguous limb leads or ST segment elevation >2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.

Excluded patients:

  • > 80 years old
  • 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 < 30 ml/min/1.73 m2)
  • with hepatic failure (Child - Pugh class B or C)
  • presenting with cardiac arrest
  • presenting with ventricular fibrillation
  • presenting with cardiogenic shock
  • with stent thrombosis
  • with angina within 48 hours before infarction
  • with previous myocardial infarction
  • with occlusion of the left main or left circumflex coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
  • with metallic implants (ferromagnetic material)
  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 identifier: NCT01936285

Athens General Hospital "G. Gennimatas" Recruiting
Athens, Greece, 11527
Contact: Spyridon Deftereos, MD    +302107768560   
Principal Investigator: Spyridon Deftereos, MD         
Sub-Investigator: Christos Angelidis, MD         
Sub-Investigator: Georgios Giannopoulos, MD         
Sponsors and Collaborators
G.Gennimatas General Hospital
  More Information

No publications provided

Responsible Party: Spyridon Deftereos, Director, Cardiac Catheterization Department, G.Gennimatas General Hospital Identifier: NCT01936285     History of Changes
Other Study ID Numbers: COL.ACS
Study First Received: September 2, 2013
Last Updated: April 22, 2015
Health Authority: Greece: Ethics Committee
Greece: National Organization of Medicines

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Antimitotic Agents
Antineoplastic Agents
Antirheumatic Agents
Gout Suppressants
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on November 27, 2015