Status: Finalised First registered on: 08/04/2015
Last updated on: 06/09/2021
1. Study identification
EU PAS Register NumberEUPAS9200
Official titleCohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort
Study title acronym
Study typeObservational study
Brief description of the studyThe primary objective of this study is to estimate, in real-world settings, the adjusted incidence rate ratio (IRR) and 95% confidence interval (CI) for major adverse cardiovascular events (MACE) in initiators of prucalopride versus initiators of polyethylene glycol 3350 (PEG). Prucalopride and PEG are both used to treat chronic constipation in women for whom laxatives do not work. The primary objective of this study is to estimate, in real-world settings, the adjusted incidence rate ratio (IRR) and 95% confidence interval (CI) for major adverse cardiovascular events (MACE) in initiators of prucalopride versus initiators of polyethylene glycol 3350 (PEG). Prucalopride and PEG are both used to treat chronic constipation in women for whom laxatives do not work. Drugs similar to prucalopride have been associated with adverse cardiovascular events in the past. This study is being done to gain a better understanding of the safety of prucalopride. The study will be implemented in five health care data sources in three countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD), The Health Improvement Network (THIN), and the Information Services Division of Scotland; in Germany, the German Pharmacoepidemiological Research Database; and in Sweden, the Swedish National Registers. Individuals in the databases will be included in the study if they were 18 years and older, were treated for chronic constipation and meet the criteria of at least 1 year of electronic data before study entry and at least 1 year of enrolment with their GP (for CPRD and THIN). The study period starts January 1, 2010, and will end at the latest available data at each database at the time of analysis. The primary cardiovascular outcome MACE, is a composite of any of the following: (1) hospitalization for nonfatal acute myocardial infarction, (2) hospitalization for nonfatal stroke, and (3) in-hospital cardiovascular death.
Was this study requested by a regulator?Yes: United States
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Gilsenan
First name Alicia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

Centre for Pharmacoepidemiology (CPE)
MEMO
BIPS GmbH
CEIFE
Countries in which this study is being conducted
International study

Germany
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/08/201429/08/2014
Start date of data collection28/02/201509/04/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/201721/12/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesShire Pharmaceuticals100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Gilsenan
First name Alicia
Address line 13040 Cornwallis Rd
Address line 2PO Box 12194 
Address line 3 
CityResearch Triangle Park 
Postcode27709 
CountryUnited States
Phone number (incl. country code)19195418745 
Alternative phone number 
Fax number (incl. country code)19195416630 
Email address agilsenan@rti.org
Public Enquiries
Title Dr 
Last name Gilsenan 
First name Alicia 
Address line 13040 Cornwallis Rd 
Address line 2PO Box 12194 
Address line 3 
CityResearch Triangle Park 
Postcode27709 
CountryUnited States 
Phone number (incl. country code)19195418745 
Alternative phone number 
Fax number (incl. country code)19195416630 
Email address agilsenan@rti.org 
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