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 group) or (3) prednisone 0.5 mg/kg/day, tapered monthly to 5-10 mg/day over 12 months (prednisone group). All groups receive background standard therapy per guidelines. The primary endpoint is angiographically confirmed ISR of the target lesion at 12 months post PCI. Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events (cardiovascular death, myocardial infarction, stroke and target vessel revascularisation), target lesion revascularisation and revascularisation of non-target coronary lesions within 12 months.
Ethics and dissemination: This trial has received ethical approval from the Ethics Committee of Fuwai Hospital (Chinese Academy of Medical Sciences…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 252 participants or records.
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