Clinical trial NCT06426537: Colchicine's Efficacy in MI Patients: Comparing PCI and Non-Reperfusion Approaches
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: ST-Elevation Myocardial Infarction
Lead sponsor: University of Brawijaya
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: mpact of Colchicine on Ventricular Remodeling in Acute ST-Elevation Myocardial Infarction (STEMI) Patients Post-PCI
timeFrame: Baseline and 1 month post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tulung Agung
country: Indonesia
facility: Tri Astiawati
state: East Java
Study officials:
affiliation: Dr. Iskak General Hospital, Tulungagung, East Java, Indonesia
name: Tri Astiawati, MD. SpJp
role: PRINCIPAL_INVESTIGATOR
References: