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NCT03735134 Clinical Trial

Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03735134
Other study ID # HYMC-99-18
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2018
Est. completion date July 2020

Study information
Verified date November 2018
Source Hillel Yaffe Medical Center
Contact Rami Abu Fanne, MD, PhD
Phone 972-50-3573694
Email ramia@hadassah.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date July 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Colchicine Loading Dose
Two milligrams of colchicine will be administrated in addition to the standard of care treatment
• Standard of care treatment prior to elective PCI
All medications normally given to patients prior to elective PCI

Locations
Country Name City State
Israel Hille Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of PPMI post elective PCI Occurrence of PPMI post elective PCI and its relation to defensin levels 24 hours post PCI
Secondary Traditional inflammatory markers Determination of traditional inflammatory markers including c-reactive protein, white blood cells and interleukin-6 24 hours post PCI
Secondary Major adverse cardiovascular events Determining the occurrence of major adverse cardiovascular events 30 days
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