MPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events.The study is a Clinical Trial that will compare the polypill (a single capsule containing aspirin, a statin [cholesterol lowering medicine], and two blood pressure lowering medicines) to the usual medicines that you take to help prevent heart attack and stroke.
- Registration Number
- CTRI/2010/091/000250
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2000
* 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.
* 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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