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RecruitingNCT07064109MCM-CATE-ACSUpdated Sep 15, 2025

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

An interventional study of Colchicine 0.5 MG Oral Tablet Once Daily in ACS - Acute Coronary Syndrome, sponsored by Shanghai Tongji Hospital, Tongji University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Shanghai Tongji Hospital, Tongji University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
380
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • ACS - Acute Coronary Syndrome

Keywords

  • ACS
  • colchicine
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Between the ages of 18 and 80
  • ACS (STEMI or NSTE-ACS)
  • Patients to receive standardised drug therapy
  • Able and willing to provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Any contraindication to colchicine or known intolerance to colchicine
  • Has been using colchicine for a prolonged period of time 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 hepatic impairment: elevated serum alanine aminotransferase and/or aminotransferase (ALT) and/or aminotransferase (AST) levels of up to three times the upper limit of normal
  • Severe renal impairment: eGFR \<30mL/min/1.73m2
  • Thrombocytopenia (platelet count less than 100*10⁹/L)
  • Active diarrhoea
  • Infectious diseases: presence of uncontrollable infectious diseases
  • Immune-related diseases: known immune diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumours, etc.
  • Strong CYP3A4 or P glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) are already in use and no alternative medications can be administered
  • Planning to use systemic anti-inflammatory therapies such as NSAIDs, hormones, immunomodulators and chemotherapeutic agents
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
380 participants (estimated)

Study arms

  • Experimental
    Colchicine treatment group

    Adding low-dose colchicine on the basis of standardized treatment

    Drug: Colchicine 0.5 MG Oral Tablet Once Daily

  • No intervention
    control group

    Standardized treatment

Interventions

  • DrugColchicine 0.5 MG Oral Tablet Once Daily

    Colchicine 0.5 MG Oral Tablet Once Daily

05

What researchers measure

Primary outcomes

  1. Number of responder

    1. Resolution of Inflammation: A reduction in high-sensitivity C-reactive protein (hs-CRP) levels to \<2.0 mg/L, or a decrease of ≥50% from baseline. 2. Clinical Stability: No occurrence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent revascularization. 3. Ventricular Remodeling: This is assessed by parameters such as ventricular volume, wall thickness, left ventricular mass, and LVEF (Left Ventricular Ejection Fraction), measured by cardiac magnetic resonance (CMR) or echocardiography.

    Time frame: 6 months after enrolment

  2. Number of Participants with Advances in Coronary Artery Physiology and Function

    Comparing the change in coronary QFR at baseline and one-year follow-up, the sum of QFR of the three major coronary vessels (anterior descending, circumflex, and right coronary artery) was calculated (3V-QFR), and progression in coronary physiology was defined when 3V-QFR minus baseline 3V-QFR at follow-up was ≤ -0.05

    Time frame: 1 year after enrolment

Secondary outcomes

  1. Incidence of MACE within one year

    MACE defined as: death (cardiac or non-cardiac), acute myocardial infarction, stroke, ischaemia-driven haemodialysis

    Time frame: 1 year after enrolment

06

Study locations

1 of 1 sites recruiting
  • Shanghai Tongji Hospital
    Shanghai, 200000, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07064109
Lead sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Responsible party
Xuebo Liu (Director, Shanghai Tongji Hospital, Tongji University School of Medicine) — Principal investigator
First posted
Jul 14, 2025
Start date
Jul 1, 2025
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Sep 15, 2025

Study contacts

Xuebo Liu
Contact
lxb70@hotmail.com
13801926702

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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