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Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

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: NCT03735134
Recruitment Status : Unknown
Verified November 2018 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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Brief Summary:
The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention.

Condition or disease Intervention/treatment Phase
Inflammation Myocardial Infarction Drug: Colchicine Loading Dose Drug: Standard of care treatment prior to elective PCI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Group
Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment
 Drug: Standard of care treatment prior to elective PCI
All medications normally given to patients prior to elective PCI
Active Comparator: Early colchicine loading dose
Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose 12-24 hours before PCI
 Drug: Colchicine Loading Dose
Two milligrams of colchicine will be administrated in addition to the standard of care treatment
Active Comparator: Late colchicine loading dose
Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose one hour prior to PCI
 Drug: Colchicine Loading Dose
Two milligrams of colchicine will be administrated in addition to the standard of care treatment


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of PPMI post elective PCI [ Time Frame: 24 hours post PCI ]
    Occurrence of PPMI post elective PCI and its relation to defensin levels


Secondary Outcome Measures :
  1. Traditional inflammatory markers [ Time Frame: 24 hours post PCI ]
    Determination of traditional inflammatory markers including c-reactive protein, white blood cells and interleukin-6

  2. Major adverse cardiovascular events [ Time Frame: 30 days ]
    Determining the occurrence of major adverse cardiovascular events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients hospitalized with troponin negative events and scheduled for elective PCI

Exclusion Criteria:

  • Significant renal dysfunction
  • Significant liver dysfunction
  • Severe left ventricular dysfunction
  • Severe low weight
  • Chronic colchicine treatment
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03735134


Contacts
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Contact: Rami Abu Fanne, MD, PhD 972-50-3573694 ramia@hadassah.org.il

Locations
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Israel
Hille Yaffe Medical Center
Hadera, Israel, 38100
Contact: Rami Abu Fanne, MD, PhD    972-503573694    ramia@hadassah.org.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03735134    
Other Study ID Numbers: HYMC-99-18
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Inflammation
Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents