UMPIRE - Use of a Multidrug Pill In Reducing cv Events (V1 04DEC09)

• Research type

  Research Study

• Full title

  UMPIRE - Use of a Multidrug Pill In Reducing cv Events - a randomised controlled trial of fixed dose combination medication and usual care in those at high risk of cardiovascular disease.

• IRAS ID

  39409

• Contact name

  S A McG Thom

• Eudract number

  2009-016278-34

• ISRCTN Number

  Not submitted

• Research summary

  The UMPIRE study aims to compare a combination medication called the ‘polypill’, (a single pill with a low dose of aspirin, a statin [cholesterol lowering medicine], and two blood pressure lowering medicines) to usual medications in subjects with established cardiovascular disease (such as people who have had a stroke or heart attack), or at high risk of cardiovascular disease (people with risk factors such as high blood pressure, high cholesterol, diabetes, smoking). The study will assess whether or not subjects prefer to take their cardiovascular preventative medicines in a single combined pill (the polypill) versus the usual form of multiple tablets, which can be difficult to remember to take or expensive. It will also look at the differences in the risk of further cardiovascular events between the two groups (polypill vs. usual care) by measuring changes in cardiovascular risk factors (blood pressure and cholesterol) between the beginning and the end of the study. It is hoped the polypill will improve adherence to prescribed medicines and consequently prevent recurrent cardiovascular events. The trial will run in Europe (U.K., Ireland and the Netherlands 1000 patients) and in India (1000 patients).

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/8

• Date of REC Opinion

  10 Feb 2010

• REC opinion

  Further Information Favourable Opinion