EUCTR2007-001493-91-NL进行中（未招募）不适用
Heart Outcomes Prevention Trial (HOPE)-3 - HOPE-3
Population Health Research Institute (PHRI), McMaster University/Hamilton Health Sciences0 个研究点目标入组 10,000 人开始时间: 2008年6月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Women aged ³ 65 years and men ³ 55 years
- •-One additional CV risk factor
- •Suggested CV risk factors for trial eligibility:
- •oWaist/hip ratio = 0.90 in men and = 0.85 in women
- •oHistory of current or recent smoking (regular tobacco use within 5 years)
- •oLow HDL cholesterol (for example, HDL cholesterol < 1.0 mmol/L [40 mg/dl]
- •in men and <1.3 mmol/L [50 mg/dl] in women)
- •oDysglycemia (impaired fasting glucose [IFG], impaired glucose tolerance
- •[IGT] or uncomplicated diabetes treated by diet only or at most one oral
- •hypoglycaemic drug)
- •oRenal dysfunction
- •-Microalbuminuria
- •-estimated GFR <60 ml/min or creatinine > 124 µmol/L (1.4 mg/dL)
- •oFamily history of premature CHD in first degree relatives (age < 55 years
- •in men or <65 years in women)
- •-Provision of informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Documented clinically manifest atherothrombotic CVD
- •-Clear indication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic
- •therapy, as determined by the subject’s own local physician
- •-Clear contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic
- •therapy, as determined by the subject’s own local physician
- •-Symptomatic hypotension
- •-Chronic liver disease (i.e. cirrhosis or persistent hepatitis) or abnormal liver function,
- •i.e. ALT or AST > 3 x upper limit of normal [ULN]
- •-Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine
- •kinase (CK) > 3 x ULN
- •-Severe renal impairment (calculated creatinine clearance [CrCl] <30 ml/min/1.73 m2
- •or serum creatinine > 264µmol/L (3.0 mg/dl)
- •-Concurrent treatment with cyclosporine or a condition likely to result in organ
- •transplantation and the need for cyclosporine
- •-Concurrent treatment with a statin or a fibrate (subjects on cholesterol-lowering
- •diets or drugs other than statins or fibrates can still be included).
- •-Concurrent treatment with an angiotensin receptor blocker, ACE inhibitor, a thiazide
- •-Other serious medical illness likely to interfere with study participation or with the
- •ability to complete the trial
- •-Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which
- •could impair the ability to provide informed consent and to adhere to the trial
- •-Concurrent use of an experimental pharmacological agent
研究者
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