ACS - Acute Coronary SyndromeMCM-CATE-ACSNCT07064109
Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients
A study testing Colchicine 0.5 MG Oral Tablet Once Daily in people with ACS - Acute Coronary Syndrome, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ACS - Acute Coronary Syndrome
- What is being tested?
- Colchicine 0.5 MG Oral Tablet Once Daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Tongji Hospital
Shanghai, 200000
Xuebo Liu, 13801926702, lxb70@hotmail.com
About this study
Official title: Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in Acute Coronary Syndromes Patients
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
- ACS - Acute Coronary Syndrome
- Being tested
- Colchicine 0.5 MG Oral Tablet Once Daily
- Keywords
- ACS, colchicine
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG Oral Tablet Once DailyDrug
Colchicine 0.5 MG Oral Tablet Once Daily
| Study group | Role | What they receive |
|---|---|---|
| Colchicine treatment group | Experimental | Adding low-dose colchicine on the basis of standardized treatment Receives: Drug: Colchicine 0.5 MG Oral Tablet Once Daily |
| control group | No intervention | Standardized treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of responder
- 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.
- 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.
- 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.
Measured: 6 months after enrolment
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
Measured: 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
Measured: 1 year after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS - Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuebo Liu, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064109
- Sponsor's protocol ID
- TJH-2025-07
- Acronym
- MCM-CATE-ACS
- Status last verified
- Sep 2025
- First submitted
- 3 Jul 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in Acute Coronary Syndromes Patients
- ClinicalTrials.gov ID
- NCT07064109
- Acronym / sponsor ID
- MCM-CATE-ACS / TJH-2025-07
- Conditions
- ACS - Acute Coronary Syndrome
- Keywords
- ACS, colchicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine treatment group | Experimental | Drug: Colchicine 0.5 MG Oral Tablet Once DailyAdding low-dose colchicine on the basis of standardized treatment |
| control group | No intervention | –Standardized treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MG Oral Tablet Once DailyColchicine 0.5 MG Oral Tablet Once Daily | Drug | Colchicine treatment group |
Primary outcome
Number of responder
Time frame: 6 months after enrolment
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.
Number of Participants with Advances in Coronary Artery Physiology and Function
Time frame: 1 year after enrolment
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
1 secondary outcome
Incidence of MACE within one year
Time frame: 1 year after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colchicine 0.5 MG Oral Tablet Once Daily in people with ACS - Acute Coronary Syndrome, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuebo Liu (13801926702, lxb70@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of responder (time frame: 6 months after enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.