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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

September 2, 2013
September 5, 2013
July 2013
March 2014   (final data collection date for primary outcome measure)
Infarct size on MRI [ Time Frame: 5 days post-MI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01936285 on ClinicalTrials.gov Archive Site
Myocardial damage marker levels [ Time Frame: Days 1-3 post-MI ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Colchicine in ST-elevation Myocardial Infarction
Study of Anti-inflammatory Treatment With Colchicine in the Acute Phase of ST-elevation Myocardial Infarction to Reduce Infarct Size
  • 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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
  • Drug: Placebo
  • Placebo Comparator: Control group
    Patients taking placebo
    Intervention: Drug: Placebo
  • Experimental: Colchicine
    Active treatment group
    Intervention: Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Not Provided
March 2014   (final data collection date for primary outcome measure)

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)
Both
up to 80 Years
No
Greece
 
NCT01936285
COL.ACS
Yes
Spyridon Deftereos, G.Gennimatas General Hospital
G.Gennimatas General Hospital
Not Provided
Not Provided
G.Gennimatas General Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP