Information for Study Investigators/Healthcare Professionals
This study was requested by the Committee for Medicinal products for Human use (CHMP), which is the European Medicines Agency’s (EMA) committee responsible for elaborating the EMA opinion on all issues regarding medicinal products, to evaluate the short term safety of rivaroxaban (Xarelto®). It is to be carried out independently by the Drug Safety Research Unit (DSRU) in Southampton, although it receives financial support from Bayer. Professor Saad Shakir is the Chief Investigator and Dr Mark De Belder is a Co-Chief Investigator.
It is a prospective, naturalistic, observational cohort study that is questionnaire based. The study aims to recruit 1193 patients started on rivaroxaban (Xarelto®) plus antiplatelet therapy over the three year data collection period.
Each individual patient will only be involved for a 13 week period of observation to ensure a minimum of 12 weeks period on treatment with rivaroxaban is captured. The study also aims to recruit 1193 patients started on dual antiplatelet therapy only (i.e. not prescribed rivaroxaban) over an equivalent data collection period.
Any patient in England and Wales will be eligible for inclusion when a clinical decision to prescribe rivaroxaban (Xarelto®) plus antiplatelet therapy or dual antiplatelet therapy only is made as part of normal clinical practice for the secondary prevention of atherothrombotic events in adults after acute coronary syndrome (ACS). We would ask the prescriber or another HCP to enrol with the DSRU to include any eligible adult patients.
We will then ask the specialist HCP or member of the care team to complete an initial questionnaire (Baseline questionnaire) after the medication has been started and then a second questionnaire (Outcome data questionnaire) at least 13 weeks after the patients hospital admission for ACS (questionnaires are downloadable from our website). If a participant has an adverse event during the 13 week observation period, we may ask the patient’s care team or the HCP responsible for the patient to fill out a further follow-up questionnaire.
The questionnaires are largely tick-box style regarding patient demographics, past medical and drug history, antiplatelet or antiplatelet and anticoagulant regimen and any adverse events experienced. No other examinations or tests will be required to be performed.
Remuneration, in line with the standard British Medical Association (BMA) rate will be paid to the NHS trust to cover time and administration costs incurred (either by specialist HCPs or associated staff) to assist with obtaining consent and completing questionnaires. The participant’s consent will be obtained to access their medical charts.