ArticleBMJ open2025
Anti-inflammatory therapy for recurrent in-stent restenosis (AI-ISR): study protocol for a prospective, randomised, open-label, multicentre clinical trial.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06090890 (Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial
Who cites it
1 citing paper in PubMed.
- Glucocorticoid Therapy for Recurrent In-Stent Restenosis: A Prospective Explorative Case Series.JACC. Case reports · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRecurrent 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 and Peking Union Medical College), which acts as the central institutional review board. All participants will provide written informed consent. Study results will be disseminated via peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT06090890. Registered 15 October 2023, https://clinicaltrials.gov/study/NCT06090890.
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