Acute Coronary SyndromeROSE ACSNCT02673437
Rivaroxaban ACS Specialist Cohort Event Monitoring Study
An observational study of Acute Coronary Syndrome, run by Drug Safety Research Unit, Southampton, UK at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- This is a non-interventional study
- How many people
- 701 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2015to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Drug Safety Research Unit (for data collation and analysis only)
Southampton, Hampshire, SO31 1AA
Drug Safety Research Unit
Southampton, Hampshire, SO31 1AA
About this study
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
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
- Being tested
- This is a non-interventional study
- Keywords
- Acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional studyOther
This is a non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban group | Patients who have been prescribed rivaroxaban and antiplatelet therapy for the prevention of atherothrombotic events following ACS. Receives: 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 Receives: Other: This is a non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startSep 2015
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drug Safety Research Unit, Southampton, UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673437
- Sponsor's protocol ID
- ROSE ACS
- Acronym
- ROSE ACS
- Status last verified
- Apr 2019
- First submitted
- 25 Jan 2016
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02673437
- Acronym / sponsor ID
- ROSE ACS / ROSE ACS
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Drug Safety Research Unit, Southampton, UKUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban group | – | Other: This is a non-interventional studyPatients who have been prescribed rivaroxaban and antiplatelet therapy for the prevention of atherothrombotic events following ACS. |
| Alternative dual antiplatelet therapy | – | Other: This is a non-interventional studyPatients who have been prescribed alternative dual antiplatelet therapy for the secondary prevention of atherothrombotic events following ACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional studyThis is a non-interventional study | Other | Alternative dual antiplatelet therapy, Rivaroxaban group |
Primary outcome
Cumulative incident risk of major bleeding, overall and stratified by the following bleeding sites: intracranial, gastrointestinal, urogenital.
Time frame: 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.
Rate of major bleeding, overall and stratified by the following bleeding sites: intracranial, gastrointestinal, urogenital.
Time frame: During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Drug Safety Research Unit, Southampton, UK at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incident risk of major bleeding, overall and stratified by the following bleeding sites: intracranial, gastrointestinal, urogenital. (time frame: During 12 weeks after initiation of treatment with rivaroxaban or alternative anticoagulant therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.