drugset / Trial / NCT07462325

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

NCT07462325

Phase 4 Not yet recruiting 176 enrolled Chinese Academy of Medical Sciences, Fuwai Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-03-01
Primary completion
2027-03-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.5 mg