Prucalopride Study

• Research type

  Research Study

• Full title

  Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort

• IRAS ID

  171091

• Contact name

  Thomas MacDonald

• Contact email

  tom@memo.dundee.ac.uk

• Sponsor organisation

  RTI Health Solutions

• Duration of Study in the UK

  3 years, 0 months, 4 days

• Research summary

  The primary objective of this study is to estimate, in real-world settings, the adjusted incidence rate ratio and 95% confidence interval for major adverse cardiovascular events, defined as the composite of hospitalization for acute myocardial infarction, hospitalisation for stroke, and in-hospital cardiovascular death—in initiators of prucalopride versus initiators of polyethylene glycol 3350, both indicated for chronic constipation, adjusting for CV risk factors and other confounders.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  15/ES/0088

• Date of REC Opinion

  1 Jul 2015

• REC opinion

  Favourable Opinion