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

NCT ID: NCT06426537

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2023-11-20

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.

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.

Conditions

ST-Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Colchicine 0.5 MG Oral Tablet

Intervention Type: DRUG

Oral administration of Colchicine in STEMI patients

Placebo in STEMI Patients Onset < 12 Hours Undergoing PCI

Patients receive placebo according to protocol: Placebo administration and OMT

Group Type: PLACEBO_COMPARATOR

Colchicine 0.5 MG Oral Tablet

Intervention Type: DRUG

Oral administration of Colchicine in STEMI patients

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

Group Type: ACTIVE_COMPARATOR

Colchicine 0.5 MG Oral Tablet

Intervention Type: DRUG

Oral administration of Colchicine in STEMI patients

Placebo in STEMI Patients Onset < 12 Hours Not Undergoing Reperfusion

Patients receive placebo according to protocol: Placebo administration and OMT

Group Type: PLACEBO_COMPARATOR

Colchicine 0.5 MG Oral Tablet

Intervention Type: DRUG

Oral administration of Colchicine in STEMI patients

Interventions

Colchicine 0.5 MG Oral Tablet

Oral administration of Colchicine in STEMI patients

Intervention Type: DRUG

Other Intervention Names

Colchicine Tablets; Generic Colchicine; Colchicine Oral Administration

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Brawijaya

OTHER

Sponsor Role: lead

Responsible Party

Tri Astiawati

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tri Astiawati, MD. SpJp

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Tri Astiawati

Tulungagung, East Java, Indonesia

Countries

Indonesia

References

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.

Reference Type: DERIVED

PMID: 40004876 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

400/235/K.3/302/2020

Identifier Type: -

Identifier Source: org_study_id