Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07462325

PHASE4

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

Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2026-03-01

Completion Date

2027-03-31

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Coronary Heart Disease (CHD)

Interventions

DRUG

colchicine

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

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.