Comparing Low-Dose Colchicine or Prednisone With Standard Drug Treatment for Patients With Recurrent In-Stent Restenosis in Coronary Arteries

What this Trial Is About

Researchers are evaluating the safety and effectiveness of different anti-inflammatory treatments in patients with coronary heart disease who have recurrent in-stent restenosis RISR, a condition where arteries narrow again after stent placement. This prospective, randomized, open-label trial compares standard drug therapy alone to standard therapy combined with low-dose colchicine or prednisone. The study aims to provide new strategies for managing RISR and is conducted at a single center in China with 252 planned participants. Participants are randomly assigned to one of three groups standard drug therapy including dual antiplatelet therapy aspirin plus a P2Y12 receptor antagonist, lipid-lowering drugs, and other necessary medications standard drugs plus low-dose colchicine 0.5 mg daily or standard drugs plus prednisone starting at 0.5 mgkg daily with a gradual dose reduction over one year. Treatments are oral and follow the specific dosing schedules, with colchicine started within 48 hours after intervention. Prednisone dosage is tapered monthly and maintained for one year after percutaneous coronary intervention PCI. During the 12-month study period, participants will be monitored for target lesion in-stent restenosis using coronary angiography, with major adverse cardiovascular events MACE such as death, heart attack, stroke, and revascularization also tracked. Safety is assessed by recording adverse reactions to colchicine and prednisone, including medication discontinuation due to side effects. Follow-up includes clinical evaluation and adherence monitoring to understand the impact of these therapies on RISR management. The total participation duration is one year post-randomization.

Anti-inflammatory Therapy for Recurrent In-stent Restenosis