Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

Not Applicable

• Conditions: Inflammation; Myocardial Infarction
• Interventions: Drug: Standard of care treatment prior to elective PCI; Drug: Colchicine Loading Dose

• Registration Number: NCT03735134
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-07
• Last Update Submitted: 2018-11-07
• Study First Posted: 2018-11-08
• Last Update Posted: 2018-11-08
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard of care treatment prior to elective PCI	Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment
Early colchicine loading dose	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
Late colchicine loading dose	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

Primary Outcome Measures

Name	Time	Method
Occurrence of PPMI post elective PCI	24 hours post PCI	Occurrence of PPMI post elective PCI and its relation to defensin levels

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hille Yaffe Medical Center; 🇮🇱 Hadera, Israel