Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07064109

Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients

Led by Shanghai Tongji Hospital, Tongji University School of Medicine · Updated on 2025-09-15

380

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of this prospective cohort study was to investigate the multi-omics characteristics of the efficacy of colchicine treatment in patients with ACS and to construct a model of efficacy. The main questions the study aims to answer are \- Specific mechanisms of colchicine therapy in patients with ACS; Mechanism-based modelling to identify the population that benefits from colchicine treatment.

CONDITIONS

Official Title

Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 18 and 80
  • Diagnosis of Acute Coronary Syndrome (STEMI or NSTE-ACS)
  • Receiving standardized drug therapy
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Any contraindication to colchicine or known intolerance to colchicine
  • Prolonged use of colchicine for other medical conditions
  • Women of childbearing age who are pregnant, breastfeeding, or not using effective contraception
  • Coronary artery bypass grafting within the last 3 years or planned
  • Severe liver impairment with elevated ALT or AST up to three times the upper limit of normal
  • Severe kidney impairment with eGFR less than 30 mL/min/1.73m2
  • Low platelet count (thrombocytopenia less than 100 x10⁹/L)
  • Active diarrhea
  • Presence of uncontrollable infectious diseases
  • Known immune-related diseases such as lupus, asthma, inflammatory bowel disease, gout, or cancer
  • Current use of strong CYP3A4 or P glycoprotein inhibitors without alternatives
  • Planning to use systemic anti-inflammatory therapies like NSAIDs, hormones, immunomodulators, or chemotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Tongji Hospital

Shanghai, China, 200000

Actively Recruiting

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Research Team

X

Xuebo Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients | DecenTrialz