Status:
COMPLETED
The Evening Versus Morning Polypill Utilization Study
Lead Sponsor:
UMC Utrecht
Conditions:
Cardiovascular Disease
Cerebrovascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background and rationale: In clinical practice, antihypertensives are generally prescribed for use in the morning, whereas some statins are recommended for use in the evening. There is evidence that ...
Detailed Description
Background and rationale: In clinical practice, antihypertensives are generally prescribed for use in the morning, whereas some statins are recommended for use in the evening. There is evidence that ...
Eligibility Criteria
Inclusion
- The participant is able to give informed consent.
- The trial Investigator considers that each of the polypill components are indicated at the doses in the Red Heart Pill
- Established atherothrombotic cardiovascular disease (CVD) or intermediate to high cardiovascular risk, defined as;
- History of coronary heart disease (myocardial infarction, stable or unstable angina pectoris, or coronary revascularisation procedure), or
- History of ischaemic cerebrovascular disease (ischaemic stroke or transient ischaemic attack), or
- History of peripheral vascular disease (peripheral revascularisation procedure or amputation due to vascular disease or aortic reconstruction), or
- For individuals without established cardiovascular disease, a calculated 5 year CVD risk of 5% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations - (Appendix 1))
Exclusion
- 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 contraindications are fully listed in the Investigator Brochures.
- The treating 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, 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).
- Any reason, medical condition, ongoing medication or significant disability that would prevent the participant complying with trial consent, treatment and follow-up procedures or potentially jeopardise her / his medical care.
- Night shift workers.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01506505
Start Date
July 1 2012
End Date
July 1 2013
Last Update
August 13 2013
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3508 GA