ISRCTN29503772已完成未知
HPS2-THRIVE: Treatment of High density lipoprotein to Reduce the Incidence of Vascular Events
niversity of Oxford (UK)0 个研究点目标入组 25,673 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 25,673
研究概览
简要总结
2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25014686 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Sufferers of one of the following:
- •1. History of myocardial infarction
- •2. Cerebrovascular atherosclerotic disease (history of presumed ischaemic stroke, transient ischaemic attack or carotid revascularisation)
- •3. Peripheral arterial disease (i.e. intermittent claudication or history of revascularisation)
- •4. 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)
排除标准
- •1. Age less than 50 or more than 80 years at invitation to screening
- •2. Less than three months since presentation with acute myocardial infarction, coronary syndrome or stroke
- •3. Planned revascularisation procedure within three months after randomisation
- •4. Definite history of chronic liver disease, or abnormal liver function (i.e. Alanine Aminotransferase [ALT] more than 1.5 x Upper Limit of Normal [ULN])
- •5. Breathlessness at rest for any reason
- •6. Severe renal insufficiency (i.e. creatinine more than 200 µmol/L)
- •7. Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or Creatine Kinase [CK] more than 3 x ULN
- •8. Previous significant adverse reaction to a statin, ezetimibe, niacin or ER niacin/laropiprant 2 g
- •9. Active peptic ulcer disease
- •10. 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, or any potent CYP3A4 inhibitor
研究者
相似试验
进行中（未招募）
1 期
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 MK 524A (ER niacin and laropipirant). - HPS2-THRIVECardiovascular disease: History of myocardial infarctionor 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.EUCTR2006-001885-17-GBCTSU, University of Oxford25,000
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-THRIVECardiovascular disease: History of myocardial infarctionor 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.MedDRA version: 14.1Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2006-001885-17-DKniversity of Oxford25,000
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-THRIVECardiovascular disease: History of myocardial infarctionor 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.MedDRA version: 9.0Level: LLTClassification code 10051615EUCTR2006-001885-17-SEniversity of Oxford20,000
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-THRIVEEUCTR2006-001885-17-FIniversity of Oxford20,000
已完成
不适用
High-Density Lipoprotein (HDL) Treatment StudyCoronary ArteriosclerosisHypoalphalipoproteinemiasGenetic Diseases, InbornNCT00458055McGill University Health Centre/Research Institute of the McGill University Health Centre19