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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - polypill - all type of patients


Related trials

TIPS, 2009 - polypill vs error



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of polypill
  • All clinical trials of polypill
  •  

    UMPIRE study,

    [NCT01057537] Ongoing trial download pdf: polypill | polypill for cardiovascular prevention

    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
    Control treatment Usual cardiovascular medications

    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 ßblocker 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)

    Trials register # NCT01057537

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