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

NCT06426537 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 400/235/K.3/302/2020
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ST-Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Colchicine Intervention in STEMI Patients Onset < 12 Hours Undergoing PCI

ACTIVE COMPARATOR

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

Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI

PLACEBO COMPARATOR

Patients receive placebo according to protocol: Placebo administration and OMT

Drug: Colchicine 0.5 MG Oral Tablet

Colchicine Intervention in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion

ACTIVE COMPARATOR

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

Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion

PLACEBO COMPARATOR

Patients receive placebo according to protocol: Placebo administration and OMT

Drug: Colchicine 0.5 MG Oral Tablet

Interventions

Colchicine 0.5 MG Oral Tablet DRUG

Oral administration of Colchicine in STEMI patients

Also known as: Colchicine Tablets, Generic Colchicine, Colchicine Oral Administration

Colchicine Intervention in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion; Colchicine Intervention in STEMI Patients Onset < 12 Hours Undergoing PCI; Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion; Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brawijaya: lead

Study Sites (1)

Tri Astiawati

Tulungagung, East Java, 66223, Indonesia

Location

Related Publications (1)

• Astiawati T, Rohman MS, Wihastuti T, Sujuti H, Endharti AT, Sargowo D, Oceandy D, Lestari B, Triastuti E, Nugraha RA. Efficacy of Colchicine in Reducing NT-proBNP, Caspase-1, TGF-beta, and Galectin-3 Expression and Improving Echocardiography Parameters in Acute Myocardial Infarction: A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Clinical Trial. J Clin Med. 2025 Feb 18;14(4):1347. doi: 10.3390/jcm14041347.

  PMID: 40004876 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Colchicine; Tablets

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Tri Astiawati, MD. SpJp

  Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subjects of this study are patients with ST-Elevation Myocardial Infarction (STEMI) who have undergone Percutaneous Coronary Intervention (PCI) and those without reperfusion. Subject selection was conducted using purposive sampling. Patients who received early PCI without reperfusion were divided into four groups: 1). Early PCI with Colchicine, 2). Early PCI with placebo, 3). STEMI without reperfusion with Colchicine and STEMI without reperfusion with placebo. This approach aims to rigorously evaluate the effects of Colchicine in managing inflammation and cardiac remodeling in STEMI patients, comparing its efficacy against standard placebo treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia

Model Details: This study investigates the impact of Colchicine on patients with ST-Elevation Myocardial Infarction (STEMI) undergoing different treatment strategies, including percutaneous coronary intervention (PCI) and no revascularization.

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: October 20, 2022
• Primary Completion: March 25, 2023
• Study Completion: November 20, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)