CL3-16257-083 - SIGNIFY Study.

• Research type

  Research Study

• Full title

  Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. Sub-Study protocol on QUALITY OF LIFE attached to CL3-16257-083 study - SIGNIFY Sub-Study protocol on PHARMACOGENOMICS attached to CL3-16257-083 study - SIGNIFY

• IRAS ID

  27428

• Contact name

  Alistair S Hall

• Sponsor organisation

  I.R.I.S (Institut de Recherches Internationales Servier)

• Eudract number

  2009-011360-10

• ISRCTN Number

  n/a

• Research summary

  The purpose of this study is to determine if a drug called ivabradine can reduce cardiovascular mortality (heart related death) or nonfatal myocardial infarction (heart attack) in comparison to placebo (a dummy drug) in adult patients over 55 years old with stable coronary artery disease without clinical heart failure, already receiving all treatments appropriate to their condition. It is hoped that this study will allow doctors to better understand and treat some forms of heart disease and that it might help some types of patient to live longer without symptoms of their disease. This is a double-blind study meaning neither the study doctor nor the patient will know if they are receiving ivabradine or placebo. Allocation of patients to either ivabradine or placebo will be random. Approximately 400 patients will be recruited from a combination of hospitals and general practices from 60 sites in the UK (11,330 patients worldwide).The planned duration of the study for patients is 18-42 months but it could be extended for up to 5 years if required for additional data. Patients will be asked to attend 6 visits with the doctor within the first six months of starting the trial, and then once every six months from then on. Sub studies:There are two additional sub-studies that patients could be involved in: 1) Quality of life: uses a questionnaire to assess the impact of treatment on a patients?? life, e.g. emotional and physical well-being. 2). Pharmacogenomics: analysis of a saliva sample will look at the different genetic factors in each participant to try to see why different people respond to heart medications in different ways.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/113

• Date of REC Opinion

  16 Nov 2009

• REC opinion

  Further Information Favourable Opinion