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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Tongji Hospital, Tongji University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Colchicine 0.5 MG Oral Tablet Once Daily

    Drug

    Colchicine 0.5 MG Oral Tablet Once Daily

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Colchicine treatment groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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