The goal of this exploratory clinical trial is to investigate the proteomic changes induced by low-dose colchicine anti-inflammatory therapy in coronary heart disease (CHD) patients, with the aim of identifying novel biomarkers and therapeutic targets.
The main questions it aims to answer are:
* Whether short-term colchicine treatment induces significant changes in the plasma proteomic profile of post-PCI CHD patients with residual inflammation. * Which specific proteins or pathways are dynamically modulated by colchicine, indicating potential mechanisms of action and drug targets. * How the proteomic expression profiles differ between patients treated with colchicine and matched controls after one month.
Participants, recruited based on a prior RCT framework, will be post-PCI CHD patients with elevated inflammation (hs-CRP ≥ 2 mg/L). A total of 176 participants will be enrolled: 88 in the trial group (colchicine 0.5 mg/day) and 88 in the matched control group (no intervention). All participants will complete a one-month follow-up. Peripheral blood samples will be collected at baseline and at the one-month visit for high-throughput proteomic analysis using Olink technology.
Diagnosis & Treatment: Have symptoms or objective evidence of myocardial ischemia and have undergone successful Percutaneous Coronary Intervention (PCI).
Recent Cardiac Event: Acute Myocardial Infarction within the past 1 month. Drug Intolerance: Known allergy or intolerance to colchicine.
Parallel
colchicine
DrugDosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed
Differentially Expressed Proteins
Using high-throughput mass spectrometry techniques (such as Olink, SOMAscan , LC-MS/MS or NULISA), the identification and quantification of differentially expressed proteins in the blood (plasma/serum) samples of patients in the colchicine treatment group and the placebo control group were compared at baseline and after treatment.
Enrichment analysis of inflammatory response pathways (such as NLRP3 inflammasome-related proteins, IL-1β, IL-6, and TNF-α pathways)
Using high-throughput mass spectrometry techniques (such as Olink, SOMAscan , LC-MS/MS, ELISA or MSD), the identification and quantification of differentially expressed proteins in the blood (plasma/serum) samples of patients in the colchicine treatment group and the placebo control group were compared at baseline and after treatment.
Genetic variants underlying the treatment-associated proteomic changes
To identify genetic variants underlying the treatment-associated proteomic changes
Validation of Candidate Biomarkers by ELISA
Top differentially expressed proteins from the primary proteomic screen will be confirmed using quantitative enzyme-linked immunosorbent assays in the entire cohort.
Measurement of Inflammatory Biomarkers
Serum levels of high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) were quantified using commercial enzyme-linked immunosorbent assay kits according to the manufacturers' instructions.
Cell-Type Deconvolution Analysis
To infer the predominant cellular origins contributing to the observed plasma proteomic changes, the investigators will perform deconvolution analysis using established reference datasets (e.g., from single-cell RNA sequencing studies of blood cells and vasculature). This will estimate the relative contributions of cell types such as neutrophils, platelets, monocytes, and endothelial cells to the protein signature.
Safety Endpoint: Incidence of Treatment-Emergent Adverse Events
The investigators will systematically collect and compare the incidence of all treatment-related adverse events (TRAEs) between groups, with a focus on colchicine-specific adverse events of special interest (AESIs), including gastrointestinal disorders (e.g., diarrhea, nausea), muscular toxicity (myopathy), and laboratory abnormalities indicative of hepatic or renal dysfunction.
The discontinuation rate due to adverse events
The between-group difference in the incidence of adverse event-related hospitalizations
Subgroup analyses to assess heterogeneity in the proteomic response based on pre-specified baseline characteristics, such as age, sex, renal function, and baseline inflammatory status.
The investigators will perform pre-specified subgroup analyses to examine whether the proteomic response to colchicine differs across key patient strata defined by: Age (\<65 vs. ≥65 years) Sex (male vs. female) Renal function (eGFR ≥60 vs. \<60 mL/min/1.73m²) Baseline high-sensitivity C-reactive protein level (above vs. below median)
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