Study identification

EU PAS number

EUPAS48079

Study ID

48112

Official title and acronym

Utilisation of low-dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the united kingdom and the netherlands

DARWIN EU® study

No

Study countries

Netherlands
United Kingdom

Study description

This study will describe the patterns in prescribing of low-dose Rivaroxaban in people diagnosed with ASCVD following the publication of the COMPASS trial, NICE and ESC recommendations. A time series analysis will be conducted in the UK CPRD Aurum data and Dutch PHARMO Database Network database, to describe the prescribing or dispensing of low-dose (2.5mg twice daily) Rivaroxaban in people with ASCVD from January 2015 to February 2022. Monthly counts of the prevalence of low-dose Rivaroxaban users and incidence of new users will be calculated in the two data sources. An interrupted time series analysis (ITS) analysis using segmented Poisson regression modelling will be conducted to estimate whether or not there was a change in prescribing of Rivaroxaban following each intervention. Several comparisons between users and non-users of low-dose rivaroxaban will characterise the patients, based on relevant comorbidities, concomitant medication user and demographic information. Associations between these covariates and the probability of receiving the prescription will be examined in a logistic regression model.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Nicholas Hunt

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

PhD project
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable