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Colchicine in ST-elevation Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01936285
Recruitment Status : Unknown
Verified April 2015 by Spyridon Deftereos, G.Gennimatas General Hospital.
Recruitment status was:  Recruiting
First Posted : September 6, 2013
Last Update Posted : April 23, 2015
Information provided by (Responsible Party):
Spyridon Deftereos, G.Gennimatas General Hospital

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2013
Estimated Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Colchicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Infarct size on MRI [ Time Frame: 5 days post-MI ]
    MRI with LGE will be performed in a subset of study participants

  2. AUC CK-MB concentration [ Time Frame: 0-3 days post-MI ]
    Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits

Secondary Outcome Measures :
  1. Myocardial damage marker levels [ Time Frame: Days 1-3 post-MI ]
    Maximal concentrations of hs-TnT and CK-MB

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01936285

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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Spyridon Deftereos, Director, Cardiac Catheterization Department, G.Gennimatas General Hospital Identifier: NCT01936285    
Other Study ID Numbers: COL.ACS
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents