Heart drug colchicine may reveal new clues to fight inflammation
NCT ID NCT07462325
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how a low dose of colchicine, an anti-inflammatory drug, changes proteins in the blood of people with coronary heart disease and high inflammation. Researchers will compare protein levels before and after one month of treatment in 176 patients. The goal is to find new biomarkers and targets for future therapies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colchicine
- What this could lead to
- If successful, this study could identify new protein targets for treating inflammation in heart disease, potentially leading to better therapies.
- What could go wrong
- This is an early exploratory study focused on protein changes, not on clinical outcomes. The results may not translate into effective treatments.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 176 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Diagnosis \& Treatment: Have symptoms or objective evidence of myocardial ischemia and have undergone successful Percutaneous Coronary Intervention (PCI). Inflammation Status: Have a plasma high-sensitivity C-reactive protein (hs-CRP) level ≥ 2 mg/L at the time of screening. Background Therapy: Be on guideline-directed standard medical therapy for coronary heart disease, tailored to their individual clinical condition. Informed Consent: The participant or their legally authorized representative must be capable of understanding the study and must provide written informed consent. Exclusion Criteria: * Recent Cardiac Event: Acute Myocardial Infarction within the past 1 month. Drug Intolerance: Known allergy or intolerance to colchicine. Hematologic Abnormalities: Platelet count \< 110 × 10⁹/L White blood cell count \< 4.0 × 10⁹/L Hemoglobin level \< 115 g/L Renal Impairment: Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m² (calculated using the MDRD formula), OR Serum creatinine level \> 2 times the upper limit of normal (ULN). Hepatic Impairment: Severe liver cirrhosis, biliary cirrhosis, or cholestasis, OR Liver enzyme (transaminase) levels \> 3 times the ULN. Bone Marrow Disorder: Known history of bone marrow hypoplasia. Severe Cardiac Conditions: New York Heart Association (NYHA) Class III-IV heart failure, OR Left Ventricular Ejection Fraction (LVEF) \< 35%, OR Moderate or severe valvular heart disease requiring intervention. Recent Cerebrovascular Event/Instability: Stroke within the past 3 months, or current cardiogenic shock or hemodynamic instability. Active Malignancy: Concurrent active tumor or cancer. Chronic Pulmonary Disease: Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung diseases. Inflammatory Bowel Disease (IBD) or Chronic Diarrhea: e.g., Crohn's disease, ulcerative colitis. Uncontrolled Comorbidities: Any other uncontrolled disease or condition that, in the investigator's judgment, would place the participant at undue risk by participating in the study. Active Systemic Inflammation/Infection: Presence of systemic inflammation or acute infection at the time of enrollment. Concurrent Steroid Use: Current use or planned initiation of systemic corticosteroid therapy during the study period (excluding topical or inhaled steroids). Pregnancy/Breastfeeding: Women who are pregnant, planning to become pregnant, or breastfeeding. Concurrent Trial Participation: Participation in another interventional clinical trial within the past 3 months that may interfere with the outcomes of this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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