Back to resultsColchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
Primary Purpose
Inflammation, Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Colchicine Loading Dose
Standard of care treatment prior to elective PCI
Sponsored by
About this trial
This is an interventional prevention trial for Inflammation
Eligibility 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
Sites / Locations
- Hille Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control Group
Early colchicine loading dose
Late colchicine loading dose
Arm Description
Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment
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
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
Outcomes
Primary Outcome Measures
Occurrence of PPMI post elective PCI
Occurrence of PPMI post elective PCI and its relation to defensin levels
Secondary Outcome Measures
Traditional inflammatory markers
Determination of traditional inflammatory markers including c-reactive protein, white blood cells and interleukin-6
Major adverse cardiovascular events
Determining the occurrence of major adverse cardiovascular events
Full Information
NCT ID
NCT03735134
First Posted
November 7, 2018
Last Updated
November 7, 2018
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03735134
Brief Title
Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
Official Title
Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Myocardial Infarction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment
Arm Title
Early colchicine loading dose
Arm Type
Active Comparator
Arm Description
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
Arm Title
Late colchicine loading dose
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Colchicine Loading Dose
Intervention Description
Two milligrams of colchicine will be administrated in addition to the standard of care treatment
Intervention Type
Drug
Intervention Name(s)
Standard of care treatment prior to elective PCI
Intervention Description
All medications normally given to patients prior to elective PCI
Primary Outcome Measure Information:
Title
Occurrence of PPMI post elective PCI
Description
Occurrence of PPMI post elective PCI and its relation to defensin levels
Time Frame
24 hours post PCI
Secondary Outcome Measure Information:
Title
Traditional inflammatory markers
Description
Determination of traditional inflammatory markers including c-reactive protein, white blood cells and interleukin-6
Time Frame
24 hours post PCI
Title
Major adverse cardiovascular events
Description
Determining the occurrence of major adverse cardiovascular events
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rami Abu Fanne, MD, PhD
Phone
972-50-3573694
Email
ramia@hadassah.org.il
Facility Information:
Facility Name
Hille Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami Abu Fanne, MD, PhD
Phone
972-503573694
Email
ramia@hadassah.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
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