NCT03742050已完成不适用
A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 12
- 主要终点
- Change in angina symptom score between groups
研究概览
简要总结
ORBITA-2 is a double blinded randomised placebo-controlled trial comparing the effects of coronary angioplasty versus placebo procedure on symptoms of stable angina without background anti-anginal therapy. Follow-up will be at 12 weeks.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ORBITA-2 will enrol patients who meet all 3 of the following criteria:
- •Angina or angina-equivalent symptoms
- •Anatomical evidence of significant coronary stenosis in at least one vessel, either: a. Invasive diagnostic coronary angiogram indicating ≥ 70% stenosis b. CT coronary angiography indicating ≥ 90% stenosis
- •Evidence of ischaemia, arising from at least one of the following options:
- •Positive dobutamine stress echocardiography
- •Positive cardiac MRI perfusion scan
- •Positive nuclear medicine myocardial perfusion scan
- •Invasive pressure wire assessment suggestive of ischaemia, as judged by the interventional cardiologist, at the time of diagnostic angiogram or research angiogram
排除标准
- •Age younger than 18
- •Age older than 85
- •Recent acute coronary event
- •Previous coronary artery bypass graft surgery
- •Significant left main stem coronary disease
- •Chronic total occlusion in the target vessel
- •Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
- •Contraindication to antiplatelet therapy
- •Severe valvular disease
- •Severe LV systolic impairment
- •Severe respiratory disease
- •Life expectancy less than 2 years, pregnancy, unable to consent
结局指标
主要结局
Change in angina symptom score between groups
时间窗: 12 weeks
次要结局
- Need for anti-anginal medication introduction and up-titration(12 weeks)
- Change in treadmill exercise time(12 weeks)
- Angina severity as assessed by Canadian Cardiovascular Society class(12 weeks)
- Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire(12 weeks)
- Quality of life as assessed with the EQ-5D-5L questionnaire(12 weeks)
- Change in dobutamine stress echocardiography score(12 weeks)
- Admission for acute coronary syndrome or unscheduled coronary angiography(12 weeks)
研究者
研究点 (12)
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