ClinicalTrials.gg
Not yet recruitingNCT07933757Updated Nov 12, 2026

AIM2-NLRP3 Inflammasome Dual Inhibitor on hsCRP

An interventional study of Colchicine and Eplerenone in Coronary Heart Disease and Inflammation, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 222 studies in Coronary Disease with a site in China — 67 open to participants now, 76 under way, 2 of them phase 3. Coronary Disease · China.

Planned enrollment
59th of 140
250 · median 220
Started
2026
with 14 others
No phase
86 of 222
27 open now
Primary completion
2027-02
later than 50 of 75 live
Registered
222nd of 222
by date

Among the 222 studies in Coronary Disease with a site in China, this one is the 59th largest by planned enrollment of the 140 interventional ones that give a count, is one of 15 that started in 2026, is one of 86 with no phase, reaches primary completion later than 50 of the 75 other live ones, and was the 222nd registered.

Coronary Disease

1,521 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.

Browse Coronary Disease studies →

Open to participants now

67 of the 222 studies in Coronary Disease with a site in China are open now. Recruiting first, the newest first:

62 more — sign in →

All 67 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 106 Coronary Disease studies recruiting now, 64 (60%) set no upper age limit and 19 (18%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Coronary Heart Disease
  • Inflammation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Volunteer to participate, understand and sign an 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

Exclusion Criteria:

  1. Known 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 (ALT) levels greater than 3 times the (ULN).
  4. Renal dysfunction, defined as an estimated (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 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 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 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 , immunomodulatory agents, chemotherapeutic agents, etc.
  14. Pregnant women, lactating women or women of childbearing age who do not use effective .
  15. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the study.
Terms in these criteria, in plain language(10)

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.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

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.

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.

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.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • No intervention
    Control group

    Standard treatment for coronary heart disease

  • Experimental
    Colchicine group

    Colchicine+standard treatment for coronary heart disease

    Drug: Colchicine

  • Experimental
    Eplerenone group

    Eplerenone+standard treatment for coronary heart disease

    Drug: Eplerenone

  • Experimental
    Leflunomide group

    Leflunomide+standard treatment for coronary heart disease

    Drug: Leflunomide

  • Experimental
    Artesunate group

    Artesunate+standard treatment for coronary heart disease

    Drug: Artesunate

Interventions

  • DrugColchicine

    Colchicine 0.5mg PO Qd

  • DrugEplerenone

    Eplerenone 50mg PO Qd

  • DrugLeflunomide

    Leflunomide 10mg PO Qd

  • DrugArtesunate

    Artesunate 50mg PO Bid

06

What researchers measure

Primary outcomes

  1. The change in hsCRP

    The change in hsCRP compared to baseline

    Time frame: 4 weeks

Secondary outcomes

  1. Major adverse cardiac and cerebrovascular event (MACCE)

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

    Time frame: 4 weeks

  2. Plasma OLINK proteomics detection

    The change in plasma OLINK proteomics

    Time frame: 4 weeks

  3. Peripheral blood mononuclear cell mass spectrometry proteomics detection

    The change in peripheral blood mononuclear cell mass spectrometry proteomics

    Time frame: 4 weeks

  4. Blood drug concentration

    Blood drug concentration in different interventions

    Time frame: 4 weeks

07

Study locations

1 site
08

References and documents

Publications

  • Yu M, Sun MY, Yang F, Yuan YF, Zhang YM, Ruan CC, Ji Y, Libby P, Cheng X. Taming inflammation in coronary artery disease: lessons learned, translational breakthroughs, and future directions. Sci Bull (Beijing). 2026 Sep 30:S2095-9273(26)01206-5. doi: 10.1016/j.scib.2026.09.081. Online ahead of print. PubMed 42888064 ↗
  • Yu M, Zhu ZF, Yang F, Yuan YF, Liao SD, Liu ML, Cheng X. Different Anti-inflammatory Drugs on High-Sensitivity C-Reactive Protein in Patients After Percutaneous Coronary Intervention: A Pilot Randomized Clinical Trial. J Cardiovasc Pharmacol. 2024 Mar 1;83(3):234-242. doi: 10.1097/FJC.0000000000001509. PubMed 37944130 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.

Of 178 non-industry interventional studies with no phase under Coronary Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 3 months is below that.

Counting every sponsor, half of 200 studies reached it within 25 months; a quarter within 14 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 10, 2026
Primary completionEst.
Feb 10, 2027
CompletionEst.
Nov 10, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933757
Responsible party
Xiang Cheng (Director, Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Feb 10, 2027 (estimated)
Completion
Nov 10, 2027 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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