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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
176
Dosage 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.
Time frame: From randomization to occurence of first event, assessed up to one year
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.
Time frame: From randomization to occurence of first event, assessed up to one year
Genetic variants underlying the treatment-associated proteomic changes
To identify genetic variants underlying the treatment-associated proteomic changes
Time frame: From randomization to occurence of first event, assessed up to one year
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.
Time frame: From randomization to occurence of first event, assessed up to one year
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.
Time frame: From randomization to occurence of first event, assessed up to one year
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.
Time frame: From randomization to occurence of first event, assessed up to one year
Comparison of hs-CRP Change Between Groups
The absolute and relative (%) change in high-sensitivity C-reactive protein levels from baseline to the end of the treatment period will be compared between the colchicine and placebo groups.
Time frame: From randomization to occurence of first event, assessed up to one year
The incidence of the composite major adverse cardiovascular event (MACE) endpoint, defined as cardiovascular death, nonfatal myocardial infarction, ischemia-driven revascularization or stroke.
Time frame: From randomization to occurence of first event, assessed up to one year
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