cardovascular disease dyslipidemia hypertension
Conditions
Interventions
Eligible individuals willing to participate in the trial will receive the
polypill and the components of the polypill for a total of 18 weeks
a random
sequence of 6 weeks morning, 6 weeks evening administration and 6 weeks
administration of the individual agents. After every treatment sequence
laboratory blood examination and ambulatory
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Difference in LDL cholesterol between treatment regimen (evening administration RHP vs. morning administration RHP) * Difference in mean 24 hour ambulatory systolic BP (evening administration RHP vs. morning administration RHP) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Difference in cholesterol spectrum (evening administration RHP vs. morning administration RHP) * Difference 24 hour ambulatory BP parameters (evening administration RHP vs. morning administration RHP) * Difference in cholesterol spectrum (administration RHP vs. administration individual agents) * Difference 24 hour ambulatory BP parameters (administration RHP vs. administration individual agents) * Diffence in cardiovascular risk score (evening administration RHP vs. morning administration RHP vs. administration individual agents) * Difference in adherence (evening administration RHP vs. morning administration RHP vs. administration individual agents) * Difference in adverse events (evening administration RHP vs. morning administration RHP vs. administration individual agents) * Difference in participant acceptability (evening administration RHP vs. morning administration RHP vs. administration individual agents) | — |
Countries
Netherlands
Outcome results
None listed