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Can colchicine tame heart inflammation? new study aims to find out

NCT ID NCT07064109

Knowledge-focused Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing colchicine, an anti-inflammatory drug, in 380 people who have had a heart attack or unstable angina. Researchers want to understand why some patients respond well and others don't, by looking at their genes, proteins, and other markers. The goal is to build a model that predicts who will benefit most from colchicine therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Colchicine 0.5 mg oral tablet once daily
What this could lead to
If successful, this could help doctors predict which heart attack patients will benefit most from colchicine, personalizing anti-inflammatory treatment.
What could go wrong
This is an observational study, not a randomized trial, so it cannot prove cause and effect. Results may not apply to all patients, and colchicine can cause side effects like stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acs (acute coronary syndrome)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Tongji Hospital

    RECRUITING

    Shanghai, 200000, China

More trials for these conditions

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