Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

NCT ID: NCT03735134

Last Updated: 2018-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment

Group Type ACTIVE_COMPARATOR

Standard of care treatment prior to elective PCI

Intervention Type DRUG

All medications normally given to patients prior to elective PCI

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

Group Type ACTIVE_COMPARATOR

Colchicine Loading Dose

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Colchicine Loading Dose

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colchicine Loading Dose

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

Intervention Type DRUG

Standard of care treatment prior to elective PCI

All medications normally given to patients prior to elective PCI

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hille Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rami Abu Fanne, MD, PhD

Role: CONTACT

972-50-3573694

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rami Abu Fanne, MD, PhD

Role: primary

972-503573694

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HYMC-99-18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.