TEMPUS - The Evening vs Morning Polypill Utilization Study;A randomised controlled cross-over trial to evaluate evening versus morning administration of a cardiovascular polypill

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

Adults with
(A) established atherothrombotic cardiovascular disease (CVD)- history of ischaemic heart disease, ischaemic stroke or transient ischaemic attack, or peripheral vascular disease
OR
(B) a 5 year cardiocvascular risk of at least 5% (SCORE)

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Difference in LDL cholesterol between treatment regimen<br /><br>(evening administration RHP vs. morning administration RHP)<br /><br>* Difference in mean 24 hour ambulatory systolic BP<br /><br>(evening administration RHP vs. morning administration RHP)</p><br>

Secondary Outcome Measures