Ignite Creation Date:
2024-05-06 @ 8:07 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02673437
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2016-01-25
Brief Title:
Rivaroxaban ACS Specialist Cohort Event Monitoring Study
Sponsor:
Drug Safety Research Unit Southampton UK
Organization:
Drug Safety Research Unit Southampton UK
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROSE ACS
Brief Summary:
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 patients 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 patients 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 patients consent the study team will also inform the patients General Practitioner GP of their participation in the study and will ask the GP to complete an abridged questionnaire from the patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None