The Evening vs Morning Polypill Utilization Study
- Conditions
- cardovascular diseasedyslipidemiahypertension100110821000796310003216
- Registration Number
- NL-OMON37659
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
Adults (>= 18 years) 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 10% (Framingham risk equation, New Zealand Guidelines Group approach).;- The trial investigator and the specialist from the department of Vascular Medicine considers that the polypill components are indicated according to current guidelines at the doses in the Red Heart Pill 2c.
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 or trial doctor considers that changing a participant*s cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose β-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(s), 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 worker
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 vs administration of<br /><br>individual agents)<br /><br><br /><br>• Difference in mean 24 hour ambulatory systolic BP between treatment regimen<br /><br>(evening administration RHP vs morning administration RHP vs administration of<br /><br>individual agents)</p><br>
- Secondary Outcome Measures
Name Time Method