Rivaroxaban ACS Specialist Cohort Event Monitoring Study

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Other: This is a non-interventional study

• Registration Number: NCT02673437
• Lead Sponsor: Drug Safety Research Unit, Southampton, UK

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-03
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 701

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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
Cumulative incident risk 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	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.

Trial Locations

Locations (2)

Drug Safety Research Unit (for data collation and analysis only); 🇬🇧 Southampton, Hampshire, United Kingdom

Drug Safety Research Unit; 🇬🇧 Southampton, Hampshire, United Kingdom