CTRI/2010/091/000250已完成3 期
A randomised controlled trial of fixed-dose combination medication and usual care in those at high risk of cardiovascular disease.Acronym: UMPIRE - Use of a Multidrug Pill In Reducing cardiovascular Events
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,000
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
入选标准
- •* Adults (≥ 18 years)
- •* The participant is able to give informed consent.
- •* Established atherothrombotic cardiovascular disease (CVD) or high cardiovascular risk, of for individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations)
- •* The trial Investigator considers that each of the polypill components are indicated
- •* The trial Investigator is unsure as to whether a polypill-based strategy or usual care is better.
排除标准
- •* Contraindication to any of the components of the polypill (e.g. known intolerance to aspirin, statins, or ACE inhibitors,pregnancy or likely to become pregnant during the treatment period).
- •* The treating doctor considers that changing a participant's cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose βblocker required to manage angina or for rate control in atrial fibrillation,accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension)
- •* Known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation.
- •* Unlikely to complete the trial (e.g. lifethreatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia).
研究者
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