ACTRN12618000809235已完成2 期
The Colchicine for coronary plaque modification in Acute Coronary Syndrome study
South Australian Health and Medical Research Insititute0 个研究点目标入组 64 人开始时间: 2018年5月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 82 Years（—）
- 性别
- All
入选标准
- •1. Participants who undergo clinically indicated coronary angiography within 72 hours of presenting with NSTEMI.
- •2. Participants able to provide written informed consent before baseline angiography.
- •3. Male or female >= 18 and <=82 years of age at screening.
- •4. Participants must meet all of the following criteria at the qualifying coronary catheterisation procedure:
- •a. Angiographic evidence of coronary artery disease, with a culprit lesion identifiable
- •for the NSTEMI, and managed as clinically indicated
- •b. Target coronary artery for OCT:
- •i. At least one non-culprit intermediate lesion in a non-culprit
- •artery, determined angiographically to be 20-50% stenotic.
- •ii. When multiple non-culprit intermediate lesions are present, the most
- •angiographically severe one will be imaged.
- •iii. Vessel for interrogation must be accessible to the OCT catheter.
- •iv. Target vessel has not undergone prior percutaneous coronary intervention
- •(PCI) or coronary artery bypass graft (CABG) surgery, and is not a bypass
- •v. Target vessel is not currently a candidate for intervention or a likely
- •candidate for intervention over the next 12 months.
- •5. Participants able to be randomised within seven days of catheterisation..
- •6. Baseline OCT interrogation determined to be of acceptable quality, and contain a lipid-rich plaque with a FCT <=120µm and lipid arc >=90° , at review by the Atherosclerosis Imaging Core Laboratory at SAHMRI.
排除标准
- •1. Left main coronary disease (>50% reduction in lumen diameter by angiographic visual estimation).
- •2. Cardiogenic shock.
- •3. Heart failure (New York Heart Association (NYHA) class IV) or LVEF <= 35%.
- •4. Participants with known gout within the last 5 years.
- •5. Currently prescribed colchicine for other indication, presence of contraindications to colchicine, or known prior intolerance to colchicine. Concomitant therapy with drugs that could interact with colchicine (eg strong CYP3A4)
- •6. Dialysis or estimated glomerular infiltration rate (eGFR) < 30 ml/min/1.73m²
- •7. Thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or >1.5x upper limit of normal (ULN)
- •8. Active liver disease or hepatic dysfunction, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the ULN as determined by analysis at screening
- •9. Known major active infection, or major haematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
- •10. Significant haematological abnormalities on assessment of complete blood picture: Hb <100 g/L, Plt <150x103 /µL, white cell count < 3.5x103 /µL.
- •11. History or malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma).
- •12. Female patients cannot be pregnant or breast feeding and premenopausal patients must be willing to use at least 1 highly effective method of birth control during treatment and for an additional 12 weeks after the end of treatment.
- •13. Unable to give informed consent.
- •14. Not willing or able to attend follow up visits or follow up OCT procedure at 12 months.
- •15. Any other information that the investigator considers will limit the ability of the patient to complete all study associated procedures
研究者
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