Trial · NCT07462325
Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease
NCT07462325, Phase 4, Not yet recruiting, Chinese Academy of Medical Sciences, Fuwai Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease. Trials, record NCT07462325. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07462325
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease
- NCT number
- NCT07462325
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 176 participants, estimated
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Conditions
- Coronary Heart Disease (CHD)
- Interventions
- colchicine
- First posted
- 2026-03-10
- Last updated
- 2026-03-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07462325
GET https://conductscience.org/api/trials/v1/NCT07462325/registered