PESCA - A Randomised Controlled Trial of a Cardiovascular Polypill Treatment Strategy Compared With Usual Care on Carotid Intima-media Thickness in Individuals at High Risk of Cardiovascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- change in intima-media (artery wall) thickness in the common carotid artery
研究概览
简要总结
Medications that lower blood pressure and cholesterol are known to improve the shape and function of our blood vessels. These improvements include a reduction in the thickness of the wall of the carotid artery (the main artery that runs up the neck to supply the brain) and a reduction in the stiffness of arteries generally including the main central artery -the aorta. Such medications are in the polypill (the Red Heart Pill) that is being used in the UMPIRE Study. In UMPIRE, patients' reported adherence to taking the single, once daily polypill is being compared to adherence to medications taken as separate tablets (usual care).The aim of the PESCA sub-study is to see whether or not the polypill differs from 'usual care' in its direct effects on blood vessels as shown by ultrasound examination of the carotid arteries and assessment of central (aortic) blood pressure.
详细描述
PESCA is a substudy of the UMPIRE clinical trial which is evaluating a 'polypill' treatment strategy for subjects with established cardiovascular disease or at high risk. All PESCA subjects will have already been recruited to UMPIRE and randomised to taking either a single 'polypill' (comprising low dose aspirin, a cholesterol-lowering statin, and one of two blood pressure lowering medicines) or their usual treatment consisting of similar medication in more than one separate tablets.
PESCA will evaluate whether: 1) progression of atherosclerosis (fatty deposits which narrow the arteries and impair blood flow to vital organs); and 2) central systolic blood pressure (the pressure in the body's main artery, the aorta, when the heart pumps out blood), are reduced in 'polypill' recipients compared to those who continue their usual treatment. Atherosclerosis and central blood pressure are both strongly associated with increased risk of heart attacks and stroke. Atherosclerosis will be assessed by ultrasound scanning of the carotid (neck) arteries to look at thickness of the artery walls (carotid intima media thickness)and plaques(fatty deposits). Direct measurement of central blood pressure is impractical but it will be estimated using a computerised "pulsecor" device. This uses an inflatable cuff on the arm but provides a detailed recording of the pressure wave as the cuff is deflated which enables "pulsecor" to calculate central blood pressure. Results from both ultrasound and blood pressure investigations will be reviewed by investigators who do not know whether the subjects have been randomised to the polypill or their usual treatment.
PESCA assessments will be conducted at 2 visits:baseline (as soon as possible after recruitment to the UMPIRE study); and at the end of both studies (which will coincide).
Parallel studies are being undertaken in the three European sites (UK, Eire and Netherlands) participating in the UMPIRE trial with each site aiming to recruit 300 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
usual medication
participants continuing to receive cardiovascular disease medications as separate tablets prescribed by their usual physician
干预措施: Usual medication (Drug)
结局指标
主要结局
change in intima-media (artery wall) thickness in the common carotid artery
时间窗: from baseline to end of trial follow up (1-2 years)
change in intima-media (artery wall) thickness and extent of atherosclerotic plaques in the carotid artery bifurcation
时间窗: from baseline to end of trial follow-up (1-2 years)
change in central aortic blood pressure
时间窗: from baseline to end of trial follow-up (1-2 years)
次要结局
未报告次要终点