Rivaroxaban ACS Specialist Cohort Event Monitoring Study (ROSE ACS)

An Observational Post-authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (XARELTO®) Initiated in Secondary Care for the Prevention of Atherothrombotic Events in Patients Who Have Had Acute Coronary Syndrome in England and Wales

Rivaroxaban is a medicine which reduces the formation of blood clots. Acute coronary syndrome (ACS) comprises a range of disorders, including heart attack and unstable angina, caused by a sudden reduction in blood flow to part of the heart muscle. This study aims to collect information on the use of rivaroxaban and its safety when used by patients for the prevention of atherothrombotic (plaque rupture leading to a blood clot) events following ACS, during the first three months after starting. This study was requested by the European regulatory body (EMA) which is responsible for the use and safety of medicines. It will last for approximately 3 years and is a national study covering the whole of England and Wales. The study aims to recruit 1193 patients who have been prescribed rivaroxaban and antiplatelet therapy and 1193 patients who have been prescribed alternative dual antiplatelet therapy for the secondary prevention of atherothrombotic events following ACS. Each patient will only be monitored for the first 13 weeks after hospital admission for ACS. Patients who choose to take part will complete a consent form. The patient's care team will be asked to complete a baseline questionnaire about the patient at the time the medicine is given and a further questionnaire up to 16 weeks later, specifically asking about the patient's experiences whilst on the medication. If anything unusual is reported during the observation period, the care team may be asked to fill out a followup questionnaire. With the patient's consent, the study team will also inform the patient's General Practitioner (GP) of their participation in the study and will ask the GP to complete an abridged questionnaire from the patient's medical records. The study team will analyse and aggregate the data, carefully protecting patient confidentiality, to classify adverse events of interest, in particular bleeding events.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: This is a non-interventional study

• Study Type: Observational
• Enrollment (Actual): 701

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO31 1AA
      • Drug Safety Research Unit (for data collation and analysis only)
    • Southampton, Hampshire, United Kingdom, SO31 1AA
      • Drug Safety Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients newly prescribed rivaroxaban in any combination with standard oral antiplatelet therapy or current standard antiplatelet combination therapy (at least dual therapy, but not monotherapy) for secondary prevention in patients after ACS

Description

Inclusion criteria:

• Age 18 years or above
• Patients newly prescribed rivaroxaban in any combination with standard oral antiplatelet therapy for the indication of secondary prevention in patients after ACS
• Patients prescribed dual antiplatelet therapy (contextual cohort) for the indication of secondary prevention after ACS
• Patients have provided signed, informed consent

Exclusion criteria:

• Patients prescribed with oral anticoagulants including rivaroxaban within 6 months prior to the index date for any indication
• Patients commenced rivaroxaban between date of market launch (28th October 2014) for the indication of secondary prevention after ACS and study start (18th September 2015)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rivaroxaban group; Patients who have been prescribed rivaroxaban and antiplatelet therapy for the prevention of atherothrombotic events following ACS.	Other: This is a non-interventional study; This is a non-interventional study
Alternative dual antiplatelet therapy; Patients who have been prescribed alternative dual antiplatelet therapy for the secondary prevention of atherothrombotic events following ACS	Other: This is a non-interventional study; This is a non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incident risk of major bleeding, overall and stratified by the following bleeding sites: intracranial, gastrointestinal, urogenital.	Cumulative incident risk of major bleeding according to the Thrombolysis In Myocardial Infarction (TIMI) classification of non-coronary artery bypass grafting (non-CABG) Related Bleeding, occurring in the 12 week observation period, overall and stratified by the following bleeding sites: intracranial, gastrointestinal, urogenital.The cumulative incidence will be calculated according to the formula: Total number of new cases during 12 week observation period x 100 / Population initially at risk If the observed cumulative incidence from this study falls within the range expected as set by the precision limits of cumulative incidence from clinical trial data, then the null hypothesis (of no difference) will not be rejected.	During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy
Rate of major bleeding, overall and stratified by the following bleeding sites: intracranial, gastrointestinal, urogenital.		During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy

Collaborators and Investigators

• Sponsor: Drug Safety Research Unit, Southampton, UK

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Acute coronary syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: ROSE ACS