Anti-inflammatory therapy for recurrent in-stent restenosis (AI-ISR): study protocol for a prospective, randomised, open-label, multicentre clinical trial.

ABSTRACT:

Introduction

Recurrent in-stent restenosis (RISR) remains a major therapeutic challenge in patients undergoing percutaneous coronary intervention (PCI), with a high incidence of repeat revascularisation and increased mortality. Immune-mediated inflammation has been implicated in the pathogenesis of RISR. This trial aims to evaluate the clinical efficacy and safety of two anti-inflammatory strategies-low-dose colchicine and prednisone-on reducing ISR recurrence and cardiovascular events.

Methods and analysis

This is a multicentre, prospective, randomised, open-label controlled trial enrolling 252 patients with RISR. Following successful PCI, patients are randomly assigned (1:1:1) to receive: (1) standard medical therapy (control group); (2) colchicine 0.5 mg/day (colchicine g

SUBMITTER: Yu M 

PROVIDER: S-EPMC12570926 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature