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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Spyridon Deftereos, G.Gennimatas General Hospital

Tracking Information
First Submitted Date  ICMJE September 2, 2013
First Posted Date  ICMJE September 6, 2013
Last Update Posted Date April 23, 2015
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Infarct size on MRI [ Time Frame: 5 days post-MI ]
    MRI with LGE will be performed in a subset of study participants
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2013)
Infarct size on MRI [ Time Frame: 5 days post-MI ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
Myocardial damage marker levels [ Time Frame: Days 1-3 post-MI ]
Maximal concentrations of hs-TnT and CK-MB
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2013)
Myocardial damage marker levels [ Time Frame: Days 1-3 post-MI ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colchicine in ST-elevation Myocardial Infarction
Official Title  ICMJE Study of Anti-inflammatory Treatment With Colchicine in the Acute Phase of ST-elevation Myocardial Infarction to Reduce Infarct Size
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
  • Drug: Placebo
Study Arms  ICMJE
  • 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
Publications * Deftereos S, Giannopoulos G, Angelidis C, Alexopoulos N, Filippatos G, Papoutsidakis N, Sianos G, Goudevenos J, Alexopoulos D, Pyrgakis V, Cleman MW, Manolis AS, Tousoulis D, Lekakis J. Anti-Inflammatory Treatment With Colchicine in Acute Myocardial Infarction: A Pilot Study. Circulation. 2015 Oct 13;132(15):1395-403. doi: 10.1161/CIRCULATIONAHA.115.017611. Epub 2015 Aug 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 22, 2015)
150
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2013)
75
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01936285
Other Study ID Numbers  ICMJE COL.ACS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spyridon Deftereos, G.Gennimatas General Hospital
Study Sponsor  ICMJE G.Gennimatas General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account G.Gennimatas General Hospital
Verification Date April 2015

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