Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease (PIC-CHD)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Coronary Heart Disease (CHD)
• Intervention / Treatment: Drug: colchicine

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No Intervention
Experimental: Colchicine group; Drug: Colchicine Dosage form: Tablets Dosage: 0.5 mg Frequency: Once daily Duration: From enrollment to the one-month follow-up visit is completed.	Drug: colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From randomization to occurence of first event, assessed up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic variants underlying the treatment-associated proteomic changes	To identify genetic variants underlying the treatment-associated proteomic changes	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.	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.	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.	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.		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.	From randomization to occurence of first event, assessed up to one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The discontinuation rate due to adverse events		From randomization to occurence of first event, assessed up to one year
The between-group difference in the incidence of adverse event-related hospitalizations		From randomization to occurence of first event, assessed up to one year
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.	From randomization to occurence of first event, assessed up to one year
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)	From randomization to occurence of first event, assessed up to one year

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; Proteomics; Precision Medicine; Colchicine; Randomized Controlled Trial (RCT); Olink; Anti-Inflammatory Therapy; High-Throughput Screening
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease; Heterocyclic Compounds; Alkaloids; Colchicine
• Other Study ID Numbers: 2025-GSP-GG-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No