None listed
Conditions
Interventions
Intervention1: Red Heart Pill: Version 1: aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg
Version 2: aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide 12.5mg.
Participants to take one capsule once daily
Control Intervention1: Usual Care: Participants in the '
Usual Care'
arm will continue to take the separate, individual medications prescribed by their usual doctor, e.g. aspirin, blood pressure lowering drugs, statins
Sponsors
Imperial College London
Eligibility
Inclusion criteria
Inclusion criteria: * Adults (≥ 18 years) * The participant is able to give informed consent. * Established atherothrombotic cardiovascular disease (CVD) or high cardiovascular risk, of for individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations) * The trial Investigator considers that each of the polypill components are indicated * The trial Investigator is unsure as to whether a polypill-based strategy or usual care is better.
Exclusion criteria
Exclusion criteria: * 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 during the treatment period). * The treating doctor considers that changing a participant's cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose βblocker required to manage angina or for rate control in atrial fibrillation,accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension) * 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. lifethreatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Changes in other lipid fractions (HDL-cholesterol, total cholesterol, Triglycerides)Timepoint: 12 months and end of trial;Dispensing of statin and (≥ 2) blood pressure lowering agents over trialTimepoint: At end of trial follow-up;New onset cardiovascular eventsTimepoint: Throughout trial;Participant 'Quality of Life' assessmentTimepoint: At 12 months and end of trial;Reasons for stopping cardiovascular medicationsTimepoint: Throughout trial;Self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapyTimepoint: At 12 months;Serious adverse eventsTimepoint: Throughout trial | — |
Primary
| Measure | Time frame |
|---|---|
| Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapyTimepoint: End of trial follow-up;Change in blood pressureTimepoint: End of trial follow-up;Change in LDL-cholesterolTimepoint: End of trial follow-up | — |
Countries
Ireland
Contacts
Public ContactDr Vinodvenkatesh Patil
Coordinating Prinicpal Investigator
Outcome results
None listed