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AIM2-NLRP3 Inflammasome Dual Inhibitor on hsCRP

The Effect of AIM2-NLRP3 Inflammasome Dual Inhibitor on hsCRP in Patients After Coronary Intervention Therapy

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.

Studieoversigt

Detaljeret beskrivelse

Despite advances in contemporary preventive and therapeutic strategies, coronary heart disease (CHD) remains a leading cause of morbidity and mortality worldwide. Residual inflammatory risk (RIR) persists in a substantial proportion of patients despite guideline-directed medical therapy and contributes to recurrent cardiovascular events, including myocardial infarction, stroke, and cardiovascular death. Accumulating evidence has established inflammation as a key driver of atherosclerotic cardiovascular disease, highlighting the need for targeted anti-inflammatory therapies to address this unmet clinical need. Notably, two large-scale randomized controlled trials, COLCOT and LoDoCo2, demonstrated that low-dose colchicine reduces cardiovascular events in patients with coronary artery disease, providing compelling clinical evidence for the therapeutic potential of targeting inflammation. These findings subsequently led to the approval of colchicine by the US Food and Drug Administration (FDA) for the reduction of cardiovascular risk in adults with established atherosclerotic cardiovascular disease.

The anti-inflammatory effects of colchicine are thought to involve the disruption of microtubule dynamics and the suppression of NLRP3 inflammasome activation, thereby attenuating downstream interleukin (IL)-1β and IL-6 signaling and reducing high-sensitivity C-reactive protein (hsCRP) levels. Among the inflammasomes implicated in cardiovascular diseases, NLRP3 and AIM2 have emerged as important contributors to inflammatory signaling in atherosclerotic disease. However, whether effective attenuation of residual inflammatory risk requires simultaneous targeting of multiple inflammasome pathways remains unclear. In our previous studies, we evaluated three pharmacological inhibitors of the NLRP3 inflammasome in patients with CHD. Notably, only colchicine, a nonselective inhibitor of NLRP3 inflammasome activation, significantly reduced hsCRP levels, whereas the more selective NLRP3 inhibitors tranilast and oridonin did not produce a comparable effect. Given that colchicine can also suppress AIM2 inflammasome activation, these findings raise the possibility that its clinical anti-inflammatory efficacy may extend beyond NLRP3 inhibition. We therefore hypothesized that concomitant inhibition of the NLRP3 and AIM2 inflammasomes may represent a more effective therapeutic strategy for mitigating residual inflammatory risk in patients with CHD.

To explore this hypothesis and identify clinically available therapeutic alternatives, we performed an integrated drug-repurposing strategy combining molecular docking-based virtual screening with functional validation in a THP-1 cell-based model of dual NLRP3 and AIM2 inflammasome activation. By integrating inhibitory efficacy against both inflammasome pathways with clinically achievable plasma drug concentrations, we identified the candidate drugs with IL-1β inhibitory activity exceeding that of colchicine: leflunomide, eplerenone, and artesunate. These findings provide a rationale for further investigating dual inflammasome inhibition as a potential therapeutic approach to targeting residual inflammatory risk in CHD.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  1. Known hypersensitivity or allergy to colchicine, eplerenone, leflunomide, or artesunate.
  2. Use of colchicine, eplerenone, leflunomide, or artesunate within 30 days before screening.
  3. Hepatic dysfunction, defined as alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal (ULN).
  4. Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m².
  5. Hyperkalemia, defined as a serum potassium level greater than 5.0 mmol/L.
  6. Thrombocytopenia, defined as a platelet count of less than 100 × 10⁹/L.
  7. Leukopenia, defined as a white blood cell count of less than 3.0 × 10⁹/L.
  8. Anemia, defined as a hemoglobin level of less than 90 g/L.
  9. Requirement for potassium supplementation or potassium-sparing diuretics, including amiloride, spironolactone, triamterene, etc.
  10. Current treatment with potent CYP3A4 inhibitors, including ketoconazole, itraconazole, clarithromycin, etc.
  11. Uncontrolled infectious diseases.
  12. Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor, etc.
  13. 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.
  14. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives.
  15. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control group

Standard treatment for coronary heart disease

Eksperimentel: Colchicine group

Colchicine+standard treatment for coronary heart disease

Colchicine 0.5mg PO Qd

Eksperimentel: Eplerenone group

Eplerenone+standard treatment for coronary heart disease

Eplerenone 50mg PO Qd

Eksperimentel: Leflunomide group

Leflunomide+standard treatment for coronary heart disease

Leflunomide 10mg PO Qd

Eksperimentel: Artesunate group

Artesunate+standard treatment for coronary heart disease

Artesunate 50mg PO Bid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change in hsCRP
Tidsramme: 4 weeks

The change in hsCRP compared to baseline

4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major adverse cardiac and cerebrovascular event (MACCE)
Tidsramme: 4 weeks

Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia

4 weeks
Plasma OLINK proteomics detection
Tidsramme: 4 weeks

The change in plasma OLINK proteomics

4 weeks
Peripheral blood mononuclear cell mass spectrometry proteomics detection
Tidsramme: 4 weeks

The change in peripheral blood mononuclear cell mass spectrometry proteomics

4 weeks
Blood drug concentration
Tidsramme: 4 weeks

Blood drug concentration in different interventions

4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. november 2026

Primær færdiggørelse (Anslået)

10. februar 2027

Studieafslutning (Anslået)

10. november 2027

Datoer for studieregistrering

Først indsendt

6. november 2026

Først indsendt, der opfyldte QC-kriterier

6. november 2026

Først opslået (Faktiske)

12. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

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