Colchicine in ST-elevation Myocardial Infarction

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by G.Gennimatas General Hospital
Sponsor:
Information provided by (Responsible Party):
Spyridon Deftereos, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier:
NCT01936285
First received: September 2, 2013
Last updated: September 5, 2013
Last verified: September 2013
  Purpose
  • 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 ]

Secondary Outcome Measures:
  • Myocardial damage marker levels [ Time Frame: Days 1-3 post-MI ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2013
Estimated Primary Completion Date: March 2014 (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

  Eligibility

Ages Eligible for Study:   up 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 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 ClinicalTrials.gov identifier: NCT01936285

Locations
Greece
Athens General Hospital "G. Gennimatas" Recruiting
Athens, Greece, 11527
Contact: Spyridon Deftereos, MD    +302107768560    spdeftereos@gmail.com   
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
ClinicalTrials.gov Identifier: NCT01936285     History of Changes
Other Study ID Numbers: COL.ACS
Study First Received: September 2, 2013
Last Updated: September 5, 2013
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
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 October 19, 2014