Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

November 7, 2018 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hille Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-99-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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