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

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: Completed
• Conditions: ST-Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Colchicine 0.5 MG Oral Tablet

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: Interventional
• Enrollment (Actual): 63
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
mpact of Colchicine on Ventricular Remodeling in Acute ST-Elevation Myocardial Infarction (STEMI) Patients Post-PCI	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

• Sponsor: University of Brawijaya
• Investigators: Principal Investigator: Tri Astiawati, MD. SpJp, Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): March 25, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID 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