Alecardio Study

• Research type

  Research Study

• Full title

  Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute acoronary syndrome (ACS) event and type 2 diabetes mellitus (T2D)

• IRAS ID

  31548

• Contact name

  Neil R Poulter

• Sponsor organisation

  F Hoffmann La Roche

• Eudract number

  2009-012269-71

• Clinicaltrials.gov Identifier

  01042769

• Research summary

  Acute Coronary Syndrome (ACS) includes both heart attacks and the development or worsening of chest pain that's gripping in nature (also referred to as unstable angina).People who suffer from Type 2 diabetes mellitus (T2DM) have poor outcomes after ACS events. The presence of T2D is confirmed by the blood sugar level criteria defined by the American diabetes association. This condition tends to occur in middle age and is often related to obesity, unhealthy eating and lack of exercise.This study looks at outcome in people who suffer from T2DM after they have been hospitalised for an ACS event. 6000 participants will be recruited from sites worldwide and approximately 400 will be included from the UK. Once consented they will be randomly allocated to receive either Aleglitazar or a placebo in addition to usual care. This will occur after a short evaluation phase to ensure participants are stable after their ACS event. Participants will then be followed up for a minimum of 2.5 years and will be seen by trial investigators at least every three months during the first year and every six months thereafter. Any later cardiovascular or other adverse events including death, heart attack and stroke will be collated and the two treatment groups compared. Further information on changes in glucose, cholesterol, blood pressure and other markers of cardiovascular risk will also be collected and examined. Aleglitazar has been shown to be well tolerated in initial studies, however, in some cases it was noted to effect kidney function. Safety measures are integral to the trial design. An independent committee will examine the data at predefined points during the trial to evaluate the safety and impact of the treatment and the trial may be stopped early if appropriate.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/6

• Date of REC Opinion

  26 Jan 2010

• REC opinion

  Further Information Favourable Opinion