See also:
All cardiovascular prevention clinical trials
All clinical trials of polypill
All clinical trials of polypill
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Treatments
Studied treatment |
fixed-dose, once-daily combination polypill, the Red Heart Pill
Red Heart Pill Version 1 and Red Heart Pill Version 2. In general, participants with a history of coronary heart disease will be given version 1, and those with a history of stroke or cerebrovascular disease will be given version 2.
Version 1 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg; Version 2 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide 12.5mg
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Control treatment |
Usual cardiovascular medications
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Patients
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 |
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 �blocker 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). |
Method and design
Randomized effectives |
NA / NA (studied vs. control) |
Design |
Parallel groups |
Blinding |
Open |
Primary endpoint |
�Adherence to medication |
Results
No results available for this trial
- ongoing study
Meta-analysis of all similar trials:
polypill in cardiovascular prevention for all type of patients
Reference(s)
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