Coronary Heart Disease (CHD)Phase 4PIC-CHDNCT07462325
Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease
A Phase 4 study testing colchicine in people with Coronary Heart Disease (CHD), run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
About this study
Official title: 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:
Read more
- 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)
- Being tested
- colchicine
- Keywords
- Colchicine, Proteomics, Biomarkers, Olink, Anti-Inflammatory Therapy, Randomized Controlled Trial (RCT), High-Throughput Screening, Precision Medicine
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colchicineDrug
Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: colchicine |
| Control group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From randomization to occurence of first event, assessed up to one year
Secondary outcomes (6)
Genetic variants underlying the treatment-associated proteomic changes
To identify genetic variants underlying the treatment-associated proteomic changes
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization to occurence of first event, assessed up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, Two-arm, Randomized, Superiority Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueyan Zhao, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462325
- Sponsor's protocol ID
- 2025-GSP-GG-13
- Acronym
- PIC-CHD
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Changes Before and After Colchicine Treatment in hsCRP-Elevated Coronary Heart Disease Patients: A Randomized Controlled Open-Label Study
- ClinicalTrials.gov ID
- NCT07462325
- Acronym / sponsor ID
- PIC-CHD / 2025-GSP-GG-13
- Conditions
- Coronary Heart Disease (CHD)
- Keywords
- Colchicine, Proteomics, Biomarkers, Olink, Anti-Inflammatory Therapy, Randomized Controlled Trial (RCT), High-Throughput Screening, Precision Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open-label, Two-arm, Randomized, Superiority Trial
| Arm | Type | Receives |
|---|---|---|
| Colchicine group | Experimental | Drug: colchicineDrug: Colchicine Dosage form: Tablets Dosage: 0.5 mg Frequency: Once daily Duration: From enrollment to the one-month follow-up visit is completed. |
| Control group | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- Recent Cardiac Event: Acute Myocardial Infarction within the past 1 month. Drug Intolerance: Known allergy or intolerance to colchicine.
- Platelet count < 110 × 10⁹/L White blood cell count < 4.0 × 10⁹/L Hemoglobin level < 115 g/L
- 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).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colchicineDosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed | Drug | Colchicine group |
Primary outcome
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.
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.
6 secondary outcomes
Genetic variants underlying the treatment-associated proteomic changes
Time frame: From randomization to occurence of first event, assessed up to one year
Validation of Candidate Biomarkers by ELISA
Time frame: From randomization to occurence of first event, assessed up to one year
Measurement of Inflammatory Biomarkers
Time frame: From randomization to occurence of first event, assessed up to one year
Cell-Type Deconvolution Analysis
Time frame: From randomization to occurence of first event, assessed up to one year
Comparison of hs-CRP Change Between Groups
Time frame: 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.
Time frame: From randomization to occurence of first event, assessed up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing colchicine in people with Coronary Heart Disease (CHD), run by Chinese Academy of Medical Sciences, Fuwai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentially Expressed Proteins (time frame: From randomization to occurence of first event, assessed up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.