Colchicine's Efficacy in MI Patients: Comparing PCI and Non-Reperfusion Approaches

May 22, 2024 updated by: Tri Astiawati, University of Brawijaya

A Comparative Study of Colchicine's Role in Reducing Cardiac Fibrosis in Acute Myocardial Infarction Patients: Evaluating Outcomes With Percutaneous Coronary Intervention Versus Without Reperfusion

This study investigates the effect of Colchicine in preventing heart structure changes following ST-segment elevation myocardial infarction. Through a clinical trial involving patients requiring coronary intervention, we explore how Colchicine can reduce inflammation and fibrosis, two crucial factors influencing heart failure post-heart attack. The outcomes are expected to offer new insights into post-heart attack treatments to prevent heart failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This clinical trial, a prospective, focuses on patients with ST-Elevation Myocardial Infarction (STEMI) requiring Percutaneous Coronary Intervention (PCI) within 12 hours of onset. The study aims to control bias effectively through randomization, evenly distributing confounding factors across two groups. Patients, unknown to both researchers and themselves whether receiving Colchicine or a placebo, will undergo reperfusion therapy and optimal medicinal treatment according to the latest guidelines. The study population includes all STEMI patients in three cities in East Java (Jember, Malang, Tulungagung), selected through purposive sampling. The independent variable is Colchicine administration, while dependent variables include ventricular remodeling assessed by Left Ventricular End-Diastolic Volume (LVEDV) via echocardiography, serum levels of caspase-1, TGF-β, NT pro BNP and Galectin-3. All patients receive standard medical treatment pre-PCI, including aspirin and antiplatelet drugs, with post-PCI Optical Medical Treatment (OMT) following the latest guidelines.

The trial is randomized, double-blinded, and placebo-controlled, with participants divided into four groups: early PCI with Colchicine or placebo, and STEMI without reperfusion, receiving either Colchicine or placebo. This setup allows for a comprehensive comparison across different patient management strategies, exploring Colchicine's potential benefits in post-AMI care and its effects on key inflammatory and fibrotic markers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

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

  • Indonesia
    • East Java
      • Tulung Agung, East Java, Indonesia, 66223
        • Tri Astiawati

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Men and women aged 18 years or older. Able and willing to provide informed consent. Presenting with clinical symptoms and supporting examinations indicative of a first-time diagnosis of IMA-EST.

Eligible for treatment according to the IMA-STEMI guidelines, which may include:

Antiplatelet therapy Renin-angiotensin-aldosterone system inhibitors Beta-blockers

Specifically, includes patients who have:

Undergone early PCI. Not received reperfusion therapy. Female patients must commit to avoiding pregnancy during the study. Willing to participate in follow-up via face-to-face or telephone contact.

Exclusion Criteria:

Presence of concurrent diseases such as infections, inflammation, or malignancy.

Diagnosed with gastrointestinal disorders including Crohn's disease, ulcerative colitis, or exhibiting chronic diarrhea.

Recent abnormal laboratory results (within the last 30 days) including:

Hemoglobin below 11.5 g/L Leukocytes below 3.0 x 10^9/L Platelets below 110 x 10^9/L ALT more than three times the upper limit of normal Total bilirubin more than twice the upper limit of normal Creatinine more than twice the upper limit of normal History of liver cirrhosis, acute hepatitis exacerbation, or severe liver disease.

Currently pregnant, breastfeeding, or planning to become pregnant during the study.

History of alcohol abuse. Receiving long-term steroid therapy or using colchicine for other indications. History of hypersensitivity to colchicine. Severe renal failure (eGFR below 30). History of cardiac arrest, ventricular fibrillation, cardiogenic shock, or hemodynamic instability.

Unwilling or unable to provide informed consent.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Colchicine Intervention in STEMI Patients Onset < 12 Hours Undergoing PCI
Patients receive colchicine according to protocol: Loading dose of 1 mg 1-2 hours before PCI, 0.5 mg colchicine 1 hour after loading, Maintenance dose of 1 x 0.5 mg colchicine for 1 month and OMT
Drug: Colchicine 0.5 MG Oral Tablet
Oral administration of Colchicine in STEMI patients
Other Names:
  • Colchicine Tablets
  • Generic Colchicine
  • Colchicine Oral Administration
Placebo Comparator: Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI
Patients receive placebo according to protocol: Placebo administration and OMT
Drug: Colchicine 0.5 MG Oral Tablet
Oral administration of Colchicine in STEMI patients
Other Names:
  • Colchicine Tablets
  • Generic Colchicine
  • Colchicine Oral Administration
Active Comparator: Colchicine Intervention in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion
Patients receive colchicine according to protocol: Loading dose of 1 mg, 0.5 mg colchicine 1 hour after loading, Maintenance dose of 1 x 0.5 mg colchicine for 1 month and OMT
Drug: Colchicine 0.5 MG Oral Tablet
Oral administration of Colchicine in STEMI patients
Other Names:
  • Colchicine Tablets
  • Generic Colchicine
  • Colchicine Oral Administration
Placebo Comparator: Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion
Patients receive placebo according to protocol: Placebo administration and OMT
Drug: Colchicine 0.5 MG Oral Tablet
Oral administration of Colchicine in STEMI patients
Other Names:
  • Colchicine Tablets
  • Generic Colchicine
  • Colchicine Oral Administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mpact of Colchicine on Ventricular Remodeling in Acute ST-Elevation Myocardial Infarction (STEMI) Patients Post-PCI
Time Frame: Baseline and 1 month post-intervention
This study assesses the impact of colchicine on ventricular remodeling by measuring changes in the expression of NLRP3 inflammasome, TGF-β, and galectin-3. These biomarkers are indicative of inflammation and fibrotic activity affecting ventricular structure and function in acute STEMI patients post-PCI or without reperfusion therapy
Baseline and 1 month post-intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Brawijaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tri Astiawati, MD. SpJp, Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 400/235/K.3/302/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

we will distribute the informed consent form and the study protocol

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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