Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05130892
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2021-11-20
Brief Title:
Effect of Inflammasome Inhibitor on hsCRP in Patients After PCI
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Effect of Inflammasome Inhibitor on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None