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

NCT07462325 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025-GSP-GG-13
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Heart Disease (CHD)

Keywords

Colchicine; Proteomics; Biomarkers; Olink; Anti-Inflammatory Therapy; Randomized Controlled Trial (RCT); High-Throughput Screening; Precision Medicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

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

• Measurement of Inflammatory Biomarkers

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

• Cell-Type Deconvolution Analysis

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

• Comparison of hs-CRP Change Between Groups

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

Other Outcomes (4)

• Safety Endpoint: Incidence of Treatment-Emergent Adverse Events

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

• 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

Study Arms (2)

Colchicine group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No Intervention

Interventions

colchicine DRUG

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

Colchicine group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

MeSH Terms

Conditions

Coronary Disease

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, M.D., FACC, FESC, Doctoral supervisor

Model Details: Open-label, Two-arm, Randomized, Superiority Trial

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03