NL-OMON35965撤回不适用
TEMPUS - The Evening vs Morning Polypill Utilization Study;A randomised controlled cross-over trial to evaluate evening versus morning administration of a cardiovascular polypill - TEMPUS
niversitair Medisch Centrum Utrecht0 个研究点目标入组 75 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 75
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Adults with
- •(A) established atherothrombotic cardiovascular disease (CVD)- history of ischaemic heart disease, ischaemic stroke or transient ischaemic attack, or peripheral vascular disease
- •(B) a 5 year cardiocvascular risk of at least 5% (SCORE)
排除标准
- •Individuals will NOT be eligible if one or more of the following criteria are satisfied:;* 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 or breastfeeding women during the treatment period). Such contrindications are fully listed in the Investigator Brochure.
- •* The treating doctor considers that changing a participant*s cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose *-blocker required to manage angina or for rate control in atrial fibrillation, accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension).;* Other potential reasons for exclusion include:
- •* 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. life-threatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia).
- •* Women of child bearing potential should be on a medically accepted form of contraception (oral or implanted contraception, IUD or tubal sterilisation). If there is any possibility of pregnancy, prior to randomisation a blood or urine pregnancy test will be performed. Final decisions about eligibility will be made at the discretion of the trial Investigator and potential trial participant, in light of any additional requirements or guidance from local ethics committees and other regulatory bodies.
- •* Night shift workers.
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