ISRCTN58452386已完成3 期
PROPS - Preventative Role of a fixed dose combination Pill in Stroke: a multi-centre open label randomised controlled trial of a fixed dose combination pill versus standard care for secondary prevention of stroke in a primary care setting
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,222
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 28/07/2015:
- •1. Men and post-menopausal* women, aged 55 years or over at the point of the database search
- •2. On the stroke/TIA register of the general practice.
- •*Post-menopausal defined as: no menstrual period for 12 consecutive months or more.
- •Previous inclusion criteria:
- •Participants eligible for the trial must comply with all of the following at randomisation:
- •1. Age 55 or over
- •2. On the stroke/TIA register of the general practice
排除标准
- •Current exclusion criteria as of 28/07/2015:
- •1. Confirmed diagnosis of haemorrhagic stroke
- •2. Currently receiving treatment with more than the equivalent of 20 mg of atorvastatin
- •3. Currently receiving treatment with clopidogrel anti-platelet monotherapy
- •4. Currently receiving treatment with anti-coagulant therapy
- •5. SBP <120mmHg
- •6. Orthostatic hypotension(=20mmHg postural drop in SBP after 1 minute of standing)
- •7. Terminal illness
- •8. Known left ventricular systolic dysfunction (ejection fraction < 30%)
- •9. Absolute contra-indication to atorvastatin, aspirin or ramipril as specified in the SmPC or British National Formulary (BNF) or hypersensitivity to these components
- •10. Inability to give informed consent
- •11. Deemed unsuitable by General Practitioner (GP) for other reasons
- •12. Women of child bearing potential
- •13. Unable to swallow tablets or capsules
- •Involvement in any other trial is not an exclusion criterion.
- •Previous exclusion criteria:
- •1. On 3 or more antihypertensive agents
- •2. On more than the equivalent of 40mg simvastatin
- •3. Systolic blood pressure < 120mmHg
- •4. Orthostatic hypotension (=20mmHg drop in systolic blood pressure on standing measured after 1 minute of standing)
- •5. Terminal illness
- •6. Heart failure
- •7. Absolute contra-indication to any of the components of the 'polypill'
- •8. Inability to give informed consent and without a designated representative who is able to provide consent under the terms of the Mental Capacity Act 2008
- •9. Deemed unsuitable by General Practitioner (GP) for other reasons
研究者
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