Sirolimus With corTicOsteroid TheraPy for Rapid rEcurrences of Coronary Unexplained In-stent Restenosis (STOP-RECUR) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 主要终点
- Target vessel failure (TVF)
研究概览
简要总结
This study aims to evaluate, through a multicenter, prospective, double-blind, randomized, placebo-controlled clinical trial, whether immunosuppressive therapy improves target lesion-related cardiovascular outcomes compared to placebo treatment in patients with Rapid rEcurrence of Coronary Unexplained in-stent Restenosis (RECUR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Able to understand the trial design and sign an informed consent form
- •Patients meeting the RECUR definition
- •Satisfactory results from revascularization within the past two weeks
- •Receiving standard secondary prevention medication for coronary heart disease with treatment targets achieved
排除标准
- •Pregnant women, individuals known to be allergic to the study drug, those currently participating in other interventional clinical trials, or participants deemed unsuitable for this study based on the investigator's judgment.
研究组 & 干预措施
Immunosuppressive therapy group
(1) prednisone + sirolimus and (2) standard coronary artery disease therapy
干预措施: Immunosuppressive therapy (Drug)
placebo control group
(1) placebo and (2) standard coronary artery disease therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Target vessel failure (TVF)
时间窗: During the 1 year follow-up
Time to first occurrence of Target vessel failure (TVF), defined as cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.
次要结局
未报告次要终点
研究者
Kefei Dou, MD
Professor
China National Center for Cardiovascular Diseases