Coronary Computed Tomography-Derived Fraction Flow Reserve (FFR)-Guided Invasive Treatment Strategy (ITS) Versus Optimal Medical Therapy (OMT) Alone in Patient With Chronic Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,066
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events (MACE)
研究概览
简要总结
The overall purpose of ACCURATE II trial is to compare the clinical outcomes of CT-derived FFR guided strategy versus medical therapy in patients with chronic coronary syndrome.
详细描述
ACCURATE II is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. CT-FFR-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. The study is powered to detect if the primary endpoint by the CT-FFR-guided strategy is superior to the medical therapy strategy.
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
- None
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, with at least one vessel has CT-derived FFR≤0.80
- •Patients with chronic coronary syndromes
- •Signed written informed consent
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled)
- •Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- •Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III)
- •Inability or unwillingness to undergo CT scan or coronary angiography
- •Patients on hemodialysis or with severe hepatic or renal insufficiency
- •Left main coronary artery stenosis ≥ 50%
- •Target vessel total occlusion
- •Pregnancy or intention to become pregnant during the course of the trial
- •Patients with a life expectancy less than 2 years
研究组 & 干预措施
CT-derived FFR guided-ITS group
CT-derived FFR≤0.8; ITS plus OMT
干预措施: ITS plus OMT (Other)
Medical therapy group
CT-derived FFR≤0.8; OMT alone
干预措施: OMT (Other)
结局指标
主要结局
Major adverse cardiac events (MACE)
时间窗: 1 year
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
次要结局
- Death(1 year)
- Revascularization(1 year)
- MACE(1 month, 2 years, 3 years, 5 years)
- Cost-effectiveness analysis(1 year)
- MI(1 year)
- Stroke(1 year)
- Quality of life assessed by Seattle Angina Questionnaire(1 year)