Anti-inflammatory Therapy for Recurrent In-stent Restenosis

Status Not yet recruiting

Clinical Trial Summary

This study is aimed at making a comparison of the safety and efficacy of standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group) in patients with coronary heart disease who suffered from recurrent In-stent restenosis (RISR).

Clinical Trial Description

This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. A total of 252 RISR patients are planned to be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group). The primary endpoint of the current study is target lesion ISR confirmed by coronary angiography for 12 months, and the secondary endpoint is Major adverse cardiovascular events (MACE: a composite of death, non-fatal myocardial infarction, non-fatal stroke, and target vascular revascularization) and each MACE component, target lesion revascularization, or other coronary artery disease revascularization for 12 months. The safety endpoint is adverse reactions to colchicine, adverse reactions of prednisone, or discontinued medication due to adverse reactions. In summary, the present study is to provide new evidence and strategy about anti-inflammatory therapy for recurrent In-stent restenosis after coronary intervention. ;

Study Design

Related Conditions & MeSH terms

In-stent Restenosis

Clinical Trial Details

NCT number	NCT06090890
Study type	Interventional
Source	Fu Wai Hospital, Beijing, China
Contact	Haiyan Qian
Phone	+8613811386143
Email	ahqhy712@163.com
Status	Not yet recruiting
Phase	Phase 4
Start date	October 30, 2023
Completion date	October 29, 2026

View Details

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