NCT00863980终止不适用
Effects of Telmisartan Compared With Candesartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients: a Multi-center, Prospective, Randomized, Open-labeled, Blinded Endpoints Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,500
- 试验地点
- 32
- 主要终点
- New or recurrent acute myocardial infarction and angina pectoris
研究概览
简要总结
This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.
详细描述
This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.
Study design: PROBE(Prospective, Randomized, Open-labeled Blind Endpoints)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are set by at least one of the three following risk factors:
- •Coronary artery disease documented by at least one of the following:
- •Myocardial infarction at least 12 months before enrollment and not planned for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- •Angina pectoris or asymptomatic myocardial ischemia undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 12 months before enrollment and not planned for further percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- •Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment
- •Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment
排除标准
- •The exclusion criteria are set as follows:
- •History of worsening of heart failure within the preceding 6 months
- •Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months
- •History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months
- •History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months
- •History of cerebral infarction, cerebral hemorrhage within the past 6 months
- •Congenital heart disease
- •Uncontrolled hypertension on treatment (eg, BP>180/110 mmHg)
- •Pregnant women or women of childbearing potential
- •Hepatic dysfunction (AST or ALT >100IU/L)
- •Renal impairment (serum creatinine level >2.0 mg per 100 ml)
- •Known hypersensitivity or intolerance to ARB
研究组 & 干预措施
Telmisartan
Experimental
Treatment with Telmisartan
干预措施: Micardis (Telmisartan) (Drug)
Candesartan
Active Comparator
Treatment with Candesartan
干预措施: Blopress (Candesartan) (Drug)
结局指标
主要结局
New or recurrent acute myocardial infarction and angina pectoris
时间窗: 3 years
次要结局
- All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus(3 years)
研究者
Hiroyuki Yamada
Department of Cardiovascular Medicine
Kyoto Prefectural University of Medicine
研究点 (32)
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