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
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 380 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Shanghai Tongji Hospital, Tongji University School of Medicine is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adding low-dose colchicine on the basis of standardized treatment
Drug: Colchicine 0.5 MG Oral Tablet Once Daily
Standardized treatment
Colchicine 0.5 MG Oral Tablet Once Daily
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
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
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
Plan to share: No
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Studies of the drug tested here: Colchicine
Shanghai Tongji Hospital, Tongji University School of Medicine