Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

RIVAROXABAN
Population studied

Short description of the study population

Patients in the secondary care hospital setting in England and Wales.
This study will be a prospective observational, population-based cohort study of rivaroxaban with a contextual comparator (reference cohort). The rivaroxaban cohort consists of new rivaroxaban users (no anticoagulant prescription within 6 months prior to index date) with any combination of oral antiplatelet therapy for the prevention of atherothrombotic events following ACS. The contextual cohort consists of patients receiving the current standard treatment of care for the prevention of atherothrombotic events following an ACS (at least dual antiplatelet therapy, but not monotherapy).

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

2386
Study design details

Main study objective

1. To quantify the cumulative incidence (risk and rate) of haemorrhage (major bleeding within intracranial, gastrointestinal and urogenital organ sites) occurring in the 12 week observation period

Outcomes

Intracranial, gastrointestinal or urogenital major bleeding.

Data analysis plan

- quantify the cumulative incidence (risk and rate) of major bleeding - descriptive exploratory analysis of patient population prescribed rivaroxaban-quantify the risk of other major (in any other site not specified in the primary objective) or minor bleeding outcomes (in any site) reported in the 12 week observation period overall