I25.1 U62.00
Conditions
Interventions
Group 1: Colchicine 0.5mg per day (oral)
Group 2: Colchicine Placebo (oral)
Sponsors
TUM Klinikum Deutsches Herzzentrum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Angiographically confirmed atherosclerotic coronary disease. - Presence of clonal hematopoiesis of indeterminate potential (CHIP), defined as the detection of a somatic mutation in a hematopoietic driver gene (e.g., DNMT3A, TET2, ASXL1, TP53, JAK2, etc.) with a variant allele frequency (VAF) = 2%. - Ability and willingness to provide written informed consent. - Willingness to comply with study procedures, including genetic and inflammatory biomarker testing, and use of a wearable device or app for activity tracking (if applicable).
Exclusion criteria
Exclusion criteria: - Known hypersensitivity or contraindication to colchicine. - Acute or chronic infection, including current SARS-CoV-2 infection or other active systemic inflammatory conditions. - Severe renal impairment, defined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m². - Severe hepatic impairment or clinically significant liver disease. - Active malignancy (other than non-melanoma skin cancer) or ongoing antineoplastic therapy. - Known diagnosis of hematologic malignancy or myelodysplastic syndrome (MDS). - Ongoing treatment with strong CYP3A4 inhibitors or P-glycoprotein inhibitors that may interact with colchicine (e.g. clarithromycin, cyclosporine). - Participation in another interventional clinical trial within the last 30 days or current enrollment in conflicting studies. - History of non-compliance, substance abuse, or other conditions that may interfere with adherence to study procedures. - Pregnancy or breastfeeding; women of childbearing potential must use adequate contraception. - Any medical or psychological condition, in the judgment of the investigator, that would make participation unsafe or data interpretation unreliable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of low-dose colchicine (0.5 mg/day) on systemic inflammation in coronary artery disease (CAD) patients with clonal hematopoiesis of indeterminate potential (CHIP). | — |
Secondary
| Measure | Time frame |
|---|---|
| The study aims to assess the safety and tolerability of colchicine in patients with coronary artery disease (CAD) and clonal hematopoiesis of indeterminate potential (CHIP). This will be evaluated by monitoring the incidence of adverse events, laboratory abnormalities, and therapy discontinuation rates. Colchicine’s effects on metabolic regulation will be examined, including markers of glucose homeostasis (such as fasting glucose and HbA1c), lipid profile (LDL-C, HDL-C, triglycerides), and indicators of mitochondrial or energy metabolism. The impact of colchicine on platelet function and immune cell phenotypes will be studied by measuring platelet activation markers (e.g., P-selectin, platelet-leukocyte aggregates) and analyzing monocyte subsets and activation profiles. Patient-reported quality of life (QoL) will be assessed using validated instruments such as the EQ-5D to determine the subjective impact of inflammation and treatment. The study will evaluate whether colchicine influences CHIP clone dynamics by examining changes in mutation burden or variant allele frequency (VAF) over time, where feasible. The effects of physical activity on inflammation-related endpoints will be analyzed using wearable-derived data (e.g., from the HerzFit app), capturing step counts, heart rate variability, and activity patterns. This will help investigate possible interaction effects between colchicine and lifestyle factors. Additionally, the study will explore biomarker-based predictors of colchicine response, with the aim of enabling future risk stratification and personalized therapy in CHIP-positive patients. Inflammatory responses will be compared across different CHIP mutation subtypes, including DNMT3A, TET2, ASXL1, TP53, JAK2, and others. The relationship between variant allele frequency and the degree of inflammatory response to colchicine will be assessed to determine if clonal burden affects treatment efficacy. Finally, the study will aim to identify c | — |
Countries
Germany
Contacts
Public ContactMoritz von Scheidt
TUM Klinikum Deutsches Herzzentrum
Outcome results
None listed