A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients With Myocardial Infarction / SYNERGY Stent Registry - Organization to Assess Strategies for Ischemic Syndromes 9

Population Health Research Institute109 个研究点分布在 5 个国家目标入组 7,264 人开始时间: 2018年2月1日最近更新: 2024年10月14日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Population Health Research Institute
入组人数: 7,264
试验地点: 109
主要终点: Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat myocardial infarction. These treatments address both the culprit artery (PCI with SYNERGY stent) as well as the non-culprit arteries (randomization to routine colchicine and spironolactone).

详细描述

This is a multicenter, international SYNERGY stent registry that is embedded within a randomized, blinded, double-dummy, 2x2 factorial design trial of colchicine versus placebo and spironolactone versus placebo in patients with myocardial infarction who have undergone primary percutaneous coronary intervention (PCI).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double-dummy masking of colchicine and spironolactone in 2x2 factorial

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

•a) Patients with STEMI referred for PCI within 12 hours of symptom onset, have a culprit lesion amenable to stenting, and with planned SYNERGY stent implantation for SYNERGY registry
•b) Patients with STEMI referred for PCI within 48 hours of symptom onset, not prospectively enrolled in SYNERGY stent registry
•c) Patients with diagnosis of Non STEMI with ischemic symptoms and either Hs Troponin > or = 300x ULN or Troponin > or = 200x ULN who have undergone PCI with one of the following:
•i. LVEF< or =45% ii. Diabetes iii. Multivessel CAD defined as 50% stenosis in 2nd major epicardial vessel iv. Prior MI v. Age >60 years
•Able to be enrolled/randomized within 72 hours of index PCI (however patients should be randomized as soon as possible after PCI)
•Written informed consent

排除标准

•Age ≤18 years
•Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
•Any medical, geographic, or social factor making study participation impractical or precluding required follow-up
•Systolic blood pressure <90 mm Hg
•Active diarrhea
•Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components
•Unable to receive dual antiplatelet therapy
•Any contraindication or known intolerance to colchicine or spironolactone
•Requirement for colchicine or mineralocorticoid antagonist for another indication
•History of cirrhosis or current severe hepatic disease
•Current or planned use of any of: cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics
•Creatinine clearance <30 mL/min/1.73 m2
•Serum Potassium >5.0 meq/L