Inhibition of cardiac fibrosis by colchicine in acute myocardial infarction

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: Patients undergoing primary and delayed percutaneous coronary intervention (PCI) are divided into two groups for each PCI type. Sample selection is through consecutive sampling, and randomization is 1:1 with double‐blind allocation. Primary PCI patients: 1. One group receives a loading dose of 1 mg colchicine 1‐2 hours before the PCI procedure, followed by 0.5 mg 1 hour afterwards, and a maintenance dose of 0.5 mg daily for 1 month, along with optimal medical therapy. 2. The other group receives a placebo following the same regimen and optimal medical therapy for 1 month. Delayed PCI Patients: 1. One group receives a loading dose of 1 mg colchicine 1‐2 hours before the PCI procedure, followed by 0.5 mg 1 hour afterwards, and a maintenance dose of 0.5 mg daily for 1 month, along with optimal medical therapy. 2. The other group receives a placebo following the same regimen and optimal medical therapy for 1 month. This design allows the researchers to observe the effects of colchicine in comparison to placebo in patients undergoing different timings of PCI while ensuring that all groups receive the standard care. CONDITION: Acute myocardial infarction ; Circulatory System PRIMARY OUTCOME: Left ventricular remodelling measured using echocardiography during hospitalization and 1 month post‐hospitalization SECONDARY OUTCOME: Biomarkers (Gal3, IL10, PIIINP and NTProBNP) measured during hospitalization and 1 month post‐hospitalization INCLUSION CRITERIA: 1. Patients diagnosed with STEMI for the first time, with the following diagnostic criteria: persistent typical chest pain >30 minutes lasting more than 12 hours, accompanied by ST‐segment elevation in at least 2 contiguous leads, and an increase in cardiac enzymes, troponin I. 2. Patients who have received information about the study and signed an informed consent. 3. Patients not pregnant, breastfeeding, or planning pregnancy during the study period. 4. Patients without a history of alcohol abuse. 5. Patients not receiving long‐term steroid therapy during the study. 6. Patients not currently taking colchicine for other indications (e.g., gout arthritis, familial Mediterranean fever).
Epistemonikos ID: 01e7878165827b0f938d7287a233bf8baebedfa2
First added on: Aug 28, 2024