EUCTR2006-001885-17-SE进行中（未招募）不适用
HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events): A randomized trial of the long-term clinical effects of raising HDL cholesterol with niacin and MK-0524. - HPS2-THRIVE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20,000
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
- •History of myocardial infarction; or
- •Cerebrovascular atherosclerotic disease (history of presumed ischaemic stroke, transient ischaemic attack or carotid revascularisation); or
- •Peripheral arterial disease (i.e. intermittent claudication or history of revascularisation); or
- •Diabetes mellitus with any of the above or with other evidence of symptomatic coronary heart disease (i.e. stable or unstable angina, or a history of coronary revascularisation or acute coronary syndrome).
- •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
- •Age <50 or >80 years at invitation to Screening;
- •Less than 3 months since presentation with acute myocardial infarction, coronary syndrome or stroke (but such patients may be entered later, if appropriate);
- •Planned revascularisation procedure within 3 months after randomization (but such patients may be entered later, if appropriate);
- •Definite history of chronic liver disease, or abnormal liver function (i.e. ALT >1.5xULN). (Note: Patients with a history of acute hepatitis are eligible provided this ALT limit is not exceeded);
- •Breathlessness at rest for any reason;
- •Severe renal insufficiency (or creatinine >200 µmol/L);
- •Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or CK >3xULN;
- •Previous significant adverse reaction to a statin, ezetimibe, niacin or MK-0524;
- •Active peptic ulcer disease;
- •Concurrent treatment with:
- •-fibric acid derivative (fibrate”)
- •-niacin (nicotinic acid) at doses more than 100 mg daily
- •-ezetimibe in combination with either simvastatin 80 mg, or atorvastatin 20-80 mg, or rosuvastatin 10-40 mg daily
- •-any potent CYP3A4 inhibitor, including: macrolide antibiotics (erythromycin, clarithromycin, telithromycin); systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole); protease inhibitors (antiretroviral drugs for HIV infection); and nefazodone
- •-ciclosporin
- •-amiodarone
- •-verapamil
- •(Note: Patients who are temporarily taking such drugs may be re-screened when they discontinue them, if considered appropriate.);
- •Known to be poorly compliant with clinic visits or prescribed medication;
- •Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer or evidence of spread within last 5 years other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)
研究者
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已完成
不适用
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