EUCTR2007-002466-35-NL进行中（未招募）1 期
A randomised placebo-controlled trial of fixed-dose combination medication in those at raised risk of cardiovascular disease - PILL Pilot
Imperial Ciollege0 个研究点目标入组 378 人开始时间: 2007年12月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 378
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
- •The trial targets individuals who have an absolute risk of a major cardiovascular event in next 5 years of at least 7.5% but who do not meet current guidelines for treatment with aspirin, or BP-lowering or cholesterol-lowering medications. Individuals are eligible for inclusion if all of the following criteria are satisfied:
- •Adults (> 18 years) with a CVD risk over 5 years of at least 7.5%, determined by the Framingham risk function using data on age, gender, BP, total cholesterol, HDL cholesterol and cigarette smoking status. The Framingham risk function will be recalibrated for each country using local incidence data from the WHO Global Burden of Disease Project. Those with an estimated 5 year risk of 5.0 – <7.5% risk would also be eligible with two additional risk factors of:
- •oBody mass index >30 kg/m2, waist circumference >102 cm in men or >88 cm in women
- •oHeart rate >80 beats/min
- •oFasting glucose 5.6 - <7.0 mmol/L
- •oTriglycerides >1.7 mmol/l
- •oFamily history of premature coronary heart disease or ischaemic stroke in a first degree male relative before the age of 55 years or a first degree female relative before the age of 65 years
- •oGlomerular filtration rate (GFR) <60 ml/min
- •No indication or contraindication for use of low-dose aspirin, ACE inhibitor, low-dose diuretic or statin.
- •The participant is able to give 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
- •Individuals will NOT be eligible if there is one or more of the following:
- •Clear indication for antiplatelet, BP lowering or cholesterol lowering medications. This includes: current treatment with BP or cholesterol lowering medicines, diabetes mellitus, existing CVD, or individuals with LDL cholesterol, systolic BP or estimated CVD risk values above those recommended for treatment by local guidelines.
- •Contraindication to any of the components of the polypill.
- •Life-limiting disease or events
研究者
相似试验
进行中（未招募）
1 期
A randomised placebo-controlled trial of fixed-dose combination medication in those at raised risk of cardiovascular disease - PILL PilotCardiovascular DiseaseEUCTR2007-002466-35-GBImperial Ciollege600
已完成
2 期
A randomised placebo-controlled trial of fixed-dose combination medication in people at raised risk of cardiovascular diseasecardiovascular1001108210003216hypertensionNL-OMON33869niversitair Medisch Centrum Utrecht105
终止
3 期
Guidelines Adherence to the Polypill Study. A clinical trial of a fixed dose combination medication (Polypill) versus usual care for improved adherence to indicated pharmacotherapy among individuals at high risk of a cardiovascular event.Cardiovascular diseaseACTRN12608000584336The George Institute for International Health1,000
已完成
3 期
MPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events.The study is a Clinical Trial that will compare the polypill (a single capsule containing aspirin, a statin [cholesterol lowering medicine], and two blood pressure lowering medicines) to the usual medicines that you take to help prevent heart attack and stroke.CTRI/2010/091/000250Imperial College London2,000
已完成
3 期
A randomised controlled trial of the efficacy of a carrageenan nasal spray when taken during a cold in reducing asthma exacerbations as measured by the asthma control questionnaire.Asthma exacerbation during a coldColdsRespiratory - AsthmaInfection - Studies of infection and infectious agentsACTRN12615001166561Julian Crane361