Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

Study Overview
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Brief Summary
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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.

Official Title
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Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

Conditions
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Inflammation, Myocardial Infarction

Intervention / Treatment
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* Drug: Colchicine Loading Dose
* Drug: Standard of care treatment prior to elective PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br>* All medications normally given to patients prior to elective PCI<br>|
| Active Comparator: Early colchicine loading dose<br>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<br>* Two milligrams of colchicine will be administrated in addition to the standard of care treatment<br>|
| Active Comparator: Late colchicine loading dose<br>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<br>* Two milligrams of colchicine will be administrated in addition to the standard of care treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of PPMI post elective PCI | Occurrence of PPMI post elective PCI and its relation to defensin levels | 24 hours post PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional inflammatory markers | Determination of traditional inflammatory markers including c-reactive protein, white blood cells and interleukin-6 | 24 hours post PCI | 
| Major adverse cardiovascular events | Determining the occurrence of major adverse cardiovascular events | 30 days |