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NCT Number: NCT07462325

Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease

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.

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Key information

Conditions

Coronary Heart Disease (CHD) Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis & Treatment: Have symptoms or objective evidence of myocardial ischemia and have undergone successful Percutaneous Coronary Intervention (PCI).

Inflammation Status: Have a plasma high-sensitivity C-reactive protein (hs-CRP) level ≥ 2 mg/L at the time of screening.

Background Therapy: Be on guideline-directed standard medical therapy for coronary heart disease, tailored to their individual clinical condition.

Informed Consent: The participant or their legally authorized representative must be capable of understanding the study and must provide written informed consent.

Exclusion criteria

  • Recent Cardiac Event: Acute Myocardial Infarction within the past 1 month. Drug Intolerance: Known allergy or intolerance to colchicine.

Hematologic Abnormalities:

Platelet count < 110 × 10⁹/L White blood cell count < 4.0 × 10⁹/L Hemoglobin level < 115 g/L

Renal Impairment:

Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² (calculated using the MDRD formula), OR Serum creatinine level > 2 times the upper limit of normal (ULN).

Hepatic Impairment:

Severe liver cirrhosis, biliary cirrhosis, or cholestasis, OR Liver enzyme (transaminase) levels > 3 times the ULN. Bone Marrow Disorder: Known history of bone marrow hypoplasia.

Severe Cardiac Conditions:

New York Heart Association (NYHA) Class III-IV heart failure, OR Left Ventricular Ejection Fraction (LVEF) < 35%, OR Moderate or severe valvular heart disease requiring intervention. Recent Cerebrovascular Event/Instability: Stroke within the past 3 months, or current cardiogenic shock or hemodynamic instability.

Active Malignancy: Concurrent active tumor or cancer. Chronic Pulmonary Disease: Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung diseases.

Inflammatory Bowel Disease (IBD) or Chronic Diarrhea: e.g., Crohn's disease, ulcerative colitis.

Uncontrolled Comorbidities: Any other uncontrolled disease or condition that, in the investigator's judgment, would place the participant at undue risk by participating in the study.

Active Systemic Inflammation/Infection: Presence of systemic inflammation or acute infection at the time of enrollment.

Concurrent Steroid Use: Current use or planned initiation of systemic corticosteroid therapy during the study period (excluding topical or inhaled steroids).

Pregnancy/Breastfeeding: Women who are pregnant, planning to become pregnant, or breastfeeding.

Concurrent Trial Participation: Participation in another interventional clinical trial within the past 3 months that may interfere with the outcomes of this study.

Treatment and study plan

Colchicine

Drug

Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed

Primary outcomes

  1. Differentially Expressed Proteins

    Time frame: 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.

  2. Enrichment analysis of inflammatory response pathways (such as NLRP3 inflammasome-related proteins, IL-1β, IL-6, and TNF-α pathways)

    Time frame: 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 outcomes

  1. Genetic variants underlying the treatment-associated proteomic changes

    Time frame: From randomization to occurence of first event, assessed up to one year

    To identify genetic variants underlying the treatment-associated proteomic changes

  2. Validation of Candidate Biomarkers by ELISA

    Time frame: 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.

  3. Measurement of Inflammatory Biomarkers

    Time frame: 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.

  4. Cell-Type Deconvolution Analysis

    Time frame: 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.

  5. Comparison of hs-CRP Change Between Groups

    Time frame: 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.

  6. 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

Other outcomes

  1. Safety Endpoint: Incidence of Treatment-Emergent Adverse Events

    Time frame: 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.

  2. The discontinuation rate due to adverse events

    Time frame: From randomization to occurence of first event, assessed up to one year

  3. The between-group difference in the incidence of adverse event-related hospitalizations

    Time frame: From randomization to occurence of first event, assessed up to one year

  4. 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.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Proteomic Changes Before and After Colchicine Treatment in hsCRP-Elevated Coronary Heart Disease Patients: A Randomized Controlled Open-Label Study

Acronym: PIC-CHD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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