NCT03735134

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

November 7, 2018

Last Update Submit

November 7, 2018

Conditions

InflammationMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Occurrence of PPMI post elective PCI

    Occurrence of PPMI post elective PCI and its relation to defensin levels

    24 hours post PCI

Secondary Outcomes (2)

  • Traditional inflammatory markers

    24 hours post PCI

  • Major adverse cardiovascular events

    30 days

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

Early colchicine loading dose

ACTIVE COMPARATOR

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

Late colchicine loading dose

ACTIVE COMPARATOR

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

Interventions

Colchicine Loading DoseDRUG

Two milligrams of colchicine will be administrated in addition to the standard of care treatment

Early colchicine loading doseLate colchicine loading dose
Standard of care treatment prior to elective PCIDRUG

All medications normally given to patients prior to elective PCI

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized with troponin negative events and scheduled for elective PCI

You may not qualify if:

  • Significant renal dysfunction
  • Significant liver dysfunction
  • Severe left ventricular dysfunction
  • Severe low weight
  • Chronic colchicine treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

InflammationMyocardial Infarction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Central Study Contacts

Rami Abu Fanne, MD, PhD

CONTACT

972-50-3573694ramia@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 8, 2018

Study Start

November 1, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)