Trial · NCT07462325
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Differentially Expressed Proteins | From randomization to occurence of first event, assessed up to one year | 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. |
| Primary | Enrichment analysis of inflammatory response pathways (such as NLRP3 inflammasome-related proteins, IL-1β, IL-6, and TNF-α pathways) | From randomization to occurence of first event, assessed up to one year | 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. |
| Secondary | Genetic variants underlying the treatment-associated proteomic changes | From randomization to occurence of first event, assessed up to one year | To identify genetic variants underlying the treatment-associated proteomic changes |
| Secondary | Validation of Candidate Biomarkers by ELISA | From randomization to occurence of first event, assessed up to one year | Top differentially expressed proteins from the primary proteomic screen will be confirmed using quantitative enzyme-linked immunosorbent assays in the entire cohort. |
| Secondary | Measurement of Inflammatory Biomarkers | From randomization to occurence of first event, assessed up to one year | 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. |
| Secondary | Cell-Type Deconvolution Analysis | From randomization to occurence of first event, assessed up to one year | 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. |
| Secondary | Comparison of hs-CRP Change Between Groups | From randomization to occurence of first event, assessed up to one year | 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. |
| Secondary | The incidence of the composite major adverse cardiovascular event (MACE) endpoint, defined as cardiovascular death, nonfatal myocardial infarction, ischemia-driven revascularization or stroke. | From randomization to occurence of first event, assessed up to one year | |
| Other | Safety Endpoint: Incidence of Treatment-Emergent Adverse Events | From randomization to occurence of first event, assessed up to one year | 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. |
| Other | The discontinuation rate due to adverse events | From randomization to occurence of first event, assessed up to one year | |
| Other | The between-group difference in the incidence of adverse event-related hospitalizations | From randomization to occurence of first event, assessed up to one year | |
| Other | 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. | From randomization to occurence of first event, assessed up to one year | 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) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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