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AIM2-NLRP3 Inflammasome Dual Inhibitor on hsCRP

Key facts

Who runs it
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
250 people, planned
Started
10 Nov 2026
Expected to end
10 Nov 2027
Type of study
Interventional, 5 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Colchicine
  • Eplerenone
  • Leflunomide
  • Artesunate
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Volunteer to participate, understand and sign an informed consent form
  • Age ≥ 18 years old, regardless of gender
  • Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention
  • Complete all planned percutaneous coronary intervention during hospitalization
  • Patient must be treated according to national guidelines for standard treatment of coronary heart disease

Who cannot take part

  • Use of colchicine, eplerenone, leflunomide, or artesunate within 30 days before screening
  • Current treatment with potent CYP3A4 inhibitors, including ketoconazole, itraconazole, clarithromycin, etc
  • Current or planned use of medications outside the study protocol that may affect immune or inflammatory responses, including nonsteroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, immunomodulatory agents, chemotherapeutic agents, etc
  • Known hypersensitivity or allergy to colchicine, eplerenone, leflunomide, or artesunate
  • Uncontrolled infectious diseases
  • Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor, etc
  • Hepatic dysfunction, defined as alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal (ULN)
  • Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m²
  • Hyperkalemia, defined as a serum potassium level greater than 5.0 mmol/L
  • Thrombocytopenia, defined as a platelet count of less than 100 × 10⁹/L
  • Leukopenia, defined as a white blood cell count of less than 3.0 × 10⁹/L
  • Anemia, defined as a hemoglobin level of less than 90 g/L
  • Requirement for potassium supplementation or potassium-sparing diuretics, including amiloride, spironolactone, triamterene, etc
  • Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives
  • Any other circumstances in which the investigator judges that the patient is not suitable to participate in the study

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Residual inflammatory risk remains a major contributor to adverse cardiovascular outcomes despite guideline-directed therapy. Although colchicine reduces cardiovascular events, its anti-inflammatory effects may extend beyond NLRP3 inhibition to involve AIM2 inflammasome suppression. We hypothesized that dual NLRP3/AIM2 inhibition may provide an effective strategy for targeting residual inflammatory risk. Using molecular docking and a THP-1 cell-based dual-inflammasome model, we screened approved drugs and identified leflunomide, eplerenone, and artesunate as candidate agents with greater IL-1β inhibitory activity than colchicine at clinically relevant concentrations. These findings highlight dual inflammasome inhibition as a potential therapeutic strategy for coronary heart disease.

The 5 groups in the trial

  • Control groupNo study treatment, for comparison

    Standard treatment for coronary heart disease

  • Colchicine groupTreatment being tested

    Colchicine+standard treatment for coronary heart disease

    Treatment: Colchicine

  • Eplerenone groupTreatment being tested

    Eplerenone+standard treatment for coronary heart disease

    Treatment: Eplerenone

  • Leflunomide groupTreatment being tested

    Leflunomide+standard treatment for coronary heart disease

    Treatment: Leflunomide

  • Artesunate groupTreatment being tested

    Artesunate+standard treatment for coronary heart disease

    Treatment: Artesunate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Effect of AIM2-NLRP3 Inflammasome Dual Inhibitor on hsCRP in Patients After Coronary Intervention Therapy
Record updated
12 November 2026