Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease (NCT07462325) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease
176 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 intervent…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differentially Expressed Proteins
Timeframe: From randomization to occurence of first event, assessed up to one year
2
Enrichment analysis of inflammatory response pathways (such as NLRP3 inflammasome-related proteins, IL-1β, IL-6, and TNF-α pathways)
Timeframe: From randomization to occurence of first event, assessed up to one year
Trial details
NCT IDNCT07462325
SponsorChinese Academy of Medical Sciences, Fuwai Hospital