{
  "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 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.",
  "authors": [
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Miao Yu"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Yu Jiang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Zhifeng Song"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Zhi-Yao Wei"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Fangshun Tan"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Xiaoyan Liu"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Xuan Zhang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Fasheng Zhu"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Yanpu Shi"
    },
    {
      "affiliations": [
        "Center for Coronary Artery Disease, Division of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung, and Blood Vessel Diseases, National Clinical Research Center for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Ji Huang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"
      ],
      "name": "Wei-Xian Yang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China",
        "Center for Coronary Artery Disease, Division of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung, and Blood Vessel Diseases, National Clinical Research Center for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Hai-Yan Qian"
    }
  ],
  "title": "Anti-inflammatory therapy for recurrent in-stent restenosis (AI-ISR): study protocol for a prospective, randomised, open-label, multicentre clinical trial",
  "uid": "5b1eb5fa-d189-5031-8193-0d56f1054403"
}