Rivaroxaban ACS Specialist Cohort Event Monitoring Study

NCT02673437 | Completed

• 1 other identifier: ROSE ACS
• Study Type: observational
• Target: 701
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

This is a non-interventional study OTHER

This is a non-interventional study

Alternative dual antiplatelet therapy; Rivaroxaban group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Drug Safety Research Unit, Southampton, UK: lead

Study Sites (2)

Drug Safety Research Unit (for data collation and analysis only)

Southampton, Hampshire, SO31 1AA, United Kingdom

Location

Drug Safety Research Unit

Southampton, Hampshire, SO31 1AA, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 3, 2016
• Study Start: September 1, 2015
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

GB (2)