NLRP3Phase 4NCT05130892
Effect of Inflammasome Inhibitor on hsCRP in Patients After PCI
A Phase 4 study testing Colchicine, Tranilast and Oridonin in people with NLRP3 and hsCRP, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
Trial summary
Coronary artery disease (CAD) comprises the major contributor to a global epidemic of cardiovascular disease. Patients with CAD undergoing percutaneous coronary intervention (PCI) have a high-risk for adverse clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NLRP3, hsCRP, Percutaneous Coronary Intervention
- What is being tested?
- Colchicine, Tranilast and Oridonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesChina
- Study dates
- 15 Nov 2021to 1 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate, and sign the informed consent form;
- Age ≥ 18 and ≤ 80 years, regardless of sex;
- Patients after completion of planned percutaneous coronary intervention for 4 weeks.
Who cannot join
- Allergic to colchicine, tranilast or oridonin;
- Taking colchicine, tranilast or oridonin before the screening period (10 days);
- Abnormal liver function (ALT > 3 times the upper limit of normal value);
- Abnormal renal function (creatinine clearance < 45 ml / min);
- Thrombocytopenia (PLT < 100g / L);
- Uncontrolled infectious diseases;
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- Complicated with immune diseases or immune related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc.
- Nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs been taken;
- History of surgery within 6 months before the screening period;
- Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
- Other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wuhan Union Hospital
Wuhan, Hubei
About this study
Official title: Effect of Inflammasome Inhibitor on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention
Coronary artery disease (CAD) comprises the major contributor to a global epidemic of cardiovascular disease. Patients with CAD undergoing percutaneous coronary intervention (PCI) have a high-risk for adverse clinical outcomes.
Residual inflammatory risk (RIR) in patients with CAD after standardized treatment is the main cause of adverse events such as recurrent myocardial infarction, stroke, and death, which has gained much interest in recent years. Inflammation plays an important role in the development of CAD. However, several randomized controlled clinical studies (RCT) of anti-inflammatory treatments ended in failure previously. Since 2017, the success of three large-scale RCTs (CANTOS, COLCOT and LoDoCo2) points to targeting the NLRP3 - IL-1 β- IL-6 pathway for anti-inflammatory treatment of CAD. The inhibition of this pathway eventually leads to the decrease of high-sensitivity C-reactive protein (hsCRP), consistent with an anti-inflammatory effect. Therefore, the change of hsCRP may serve as a biomarker to screen anti-inflammatory drugs in this pathway.
Targeting the NLRP3 - IL-1 β- IL-6 pathway with monoclonal antibodies is limited by high prices of the biological agents. Thus, researchers focused on the upstream molecule NLRP3. Currently, NLRP3 inhibitors that are clinically available include colchicine , tranilast and oridonin. Although several studies have indicated the effective effects of colchicine in CAD, the other two NLRP3 inhibitors lack sufficient data on anti-inflammatory treatment of CAD. Therefore, we intend to use NLRP3 inhibitors (colchicine, tranilast and oridonin) to treat patients after PCI for 4 weeks, compare the changes of hsCRP, and explore the effectiveness and safety of these different drugs, and screen the optimal anti-inflammatory drugs for coronary heart disease.
- Conditions
- NLRP3, hsCRP, Percutaneous Coronary Intervention
- Being tested
- Colchicine, Tranilast, Oridonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
1 tablet (0.5mg) / time, once a day
TranilastDrug
1 capsule (0.1g) / time, 3 times a day
OridoninDrug
2 tablets (0.5g) / time, 3 times a day;
| Study group | Role | What they receive |
|---|---|---|
| Colchicine group | Experimental | 1 tablet (0.5mg) / time, once a day Receives: Drug: Colchicine |
| Tranilast group | Experimental | 1 capsule (0.1g) / time, 3 times a day; Receives: Drug: Tranilast |
| Oridonin group | Experimental | 2 tablets (0.5g) / time, 3 times a day Receives: Drug: Oridonin |
| Non-intervention group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in hsCRP
Percentage change in hsCRP at the end of 4 weeks compared with baseline
Measured: 4 weeks
Secondary outcomes (3)
MACE (composite endpoint of all-cause death, nonfatal myocardial infarction, nonfatal stroke, revascularization due to ischemia, or hospitalization due to unstable angina pectoris)
Time to occurrence of MACE
Measured: 4 weeks
Bleeding
Time to occurrence of bleeding
Measured: 4 weeks
Proteomics analysis
Proteomics analysis using cardiovascular II/III panel by Olink company
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start15 Nov 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NLRP3Studies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Cheng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130892
- Sponsor's protocol ID
- NLRP3-CRP
- Status last verified
- Feb 2023
- First submitted
- 20 Nov 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inflammasome Inhibitor on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT05130892
- Acronym / sponsor ID
- NLRP3-CRP
- Conditions
- NLRP3, hsCRP, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary artery disease (CAD) comprises the major contributor to a global epidemic of cardiovascular disease. Patients with CAD undergoing percutaneous coronary intervention (PCI) have a high-risk for adverse clinical outcomes.
Residual inflammatory risk (RIR) in patients with CAD after standardized treatment is the main cause of adverse events such as recurrent myocardial infarction, stroke, and death, which has gained much interest in recent years. Inflammation plays an important role in the development of CAD. However, several randomized controlled clinical studies (RCT) of anti-inflammatory treatments ended in failure previously. Since 2017, the success of three large-scale RCTs (CANTOS, COLCOT and LoDoCo2) points to targeting the NLRP3 - IL-1 β- IL-6 pathway for anti-inflammatory treatment of CAD. The inhibition of this pathway eventually leads to the decrease of high-sensitivity C-reactive protein (hsCRP), consistent with an anti-inflammatory effect. Therefore, the change of hsCRP may serve as a biomarker to screen anti-inflammatory drugs in this pathway.
Targeting the NLRP3 - IL-1 β- IL-6 pathway with monoclonal antibodies is limited by high prices of the biological agents. Thus, researchers focused on the upstream molecule NLRP3. Currently, NLRP3 inhibitors that are clinically available include colchicine , tranilast and oridonin. Although several studies have indicated the effective effects of colchicine in CAD, the other two NLRP3 inhibitors lack sufficient data on anti-inflammatory treatment of CAD. Therefore, we intend to use NLRP3 inhibitors (colchicine, tranilast and oridonin) to treat patients after PCI for 4 weeks, compare the changes of hsCRP, and explore the effectiveness and safety of these different drugs, and screen the optimal anti-inflammatory drugs for coronary heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Colchicine group | Experimental | Drug: Colchicine1 tablet (0.5mg) / time, once a day |
| Tranilast group | Experimental | Drug: Tranilast1 capsule (0.1g) / time, 3 times a day; |
| Oridonin group | Experimental | Drug: Oridonin2 tablets (0.5g) / time, 3 times a day |
| Non-intervention group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily participate, and sign the informed consent form;
- Age ≥ 18 and ≤ 80 years, regardless of sex;
- Patients after completion of planned percutaneous coronary intervention for 4 weeks.
Key exclusion criteria (11 listed)
- Allergic to colchicine, tranilast or oridonin;
- Taking colchicine, tranilast or oridonin before the screening period (10 days);
- Abnormal liver function (ALT > 3 times the upper limit of normal value);
- Abnormal renal function (creatinine clearance < 45 ml / min);
- Thrombocytopenia (PLT < 100g / L);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine1 tablet (0.5mg) / time, once a day | Drug | Colchicine group |
| Tranilast1 capsule (0.1g) / time, 3 times a day | Drug | Tranilast group |
| Oridonin2 tablets (0.5g) / time, 3 times a day; | Drug | Oridonin group |
Primary outcome
Percentage change in hsCRP
Time frame: 4 weeks
Percentage change in hsCRP at the end of 4 weeks compared with baseline
3 secondary outcomes
MACE (composite endpoint of all-cause death, nonfatal myocardial infarction, nonfatal stroke, revascularization due to ischemia, or hospitalization due to unstable angina pectoris)
Time frame: 4 weeks
Bleeding
Time frame: 4 weeks
Proteomics analysis
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine, Tranilast and Oridonin in people with NLRP3 and hsCRP, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in hsCRP (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.