Non-valvular Atrial FibrillationREACT-AF2NCT02488421
Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF2
An observational study of Non-valvular Atrial Fibrillation, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to determine and compare the persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- How many people
- 38,122 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jul 2016
- 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: Primary Care Clinic
Who may be able to join
- Have an apixaban, rivaroxaban, dabigatran or VKA prescription during the study period
- Are ≥18 years old at index date
- Have ≥12 months of computerised medical data prior to index date
- Have a record of AF on or ever prior to index date (index OAC prescription)
Who cannot join
- Have a record for a valvular condition (ie, rheumatic valvular disease and prosthetic valves) on or ever prior to index date
- Have a history (ever prior to index date) of the Oral anticoagulant (OACs) which are prescribed during the study period
About this study
Official title: Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF 2
The purpose of this study is to determine and compare the persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF.
Read the detailed description
Actual number of patients enrolled for UK : 15242 patients
Actual number of patients enrolled for Germany : 22880 patients
- Conditions
- Non-valvular Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with Apixaban | Not described | |
| Patient treated with Rivaroxaban | Not described | |
| Patient treated with Dabigatran | Not described | |
| Patient treated with vitamin K antagonists | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF)
We defined non-persistence in the databases as the absence of index prescription for twice the median prescription duration; and calculated cumulative incidence (95% CIs) of persistence at the end of follow-up and at different time points after treatment initiation (3, 6, and 12 months)
Measured: 23 months for the UK and Germany, 25 months for France
Secondary outcomes (4)
Demographic characteristics (Age, Gender, Smoking status, region of practice, data source) of patients with newly prescribed oral anticoagulants
Measured: 23 months for the UK and Germany, 25 months for France
Clinical characteristics (History of bleeding, myocardial infarction, stroke, Thromboembolism, congestive heart failure, vascular disease, hypertension, CHA2DS2-VASc score, HAS-BLED score, etc) of patients with newly prescribed oral anticoagulants
Measured: 23 months for the UK and Germany, 25 months for France
Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR)
Measured: 23 months for the UK and Germany
Compare persistence rates across oral anticoagulant therapies
Measured: 23 months for the UK and Germany, 25 months for France
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 38,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IMS Health, OXON Epidemiology
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488421
- Sponsor's protocol ID
- CV185-371
- Acronym
- REACT-AF2
- Status last verified
- Dec 2016
- First submitted
- 18 Jun 2015
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Collings SL, Vannier-Moreau V, Johnson ME, Stynes G, Lefevre C, Maguire A, Asmar J, Bizouard G, Duhot D, Mouquet F, Fauchier L. Initiation and continuation of oral anticoagulant prescriptions for stroke prevention in non-valvular atrial fibrillation: A cohort study in primary care in France. Arch Cardiovasc Dis. 2018 May;111(5):370-379. doi: 10.1016/j.acvd.2017.10.003. Epub 2018 Feb 3.
PubMed 29398546Johnson ME, Lefevre C, Collings SL, Evans D, Kloss S, Ridha E, Maguire A. Early real-world evidence of persistence on oral anticoagulants for stroke prevention in non-valvular atrial fibrillation: a cohort study in UK primary care. BMJ Open. 2016 Sep 26;6(9):e011471. doi: 10.1136/bmjopen-2016-011471.
PubMed 27678530
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF 2
- ClinicalTrials.gov ID
- NCT02488421
- Acronym / sponsor ID
- REACT-AF2 / CV185-371
- Conditions
- Non-valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38,122 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- IMS Health, OXON Epidemiology
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Jul 2015 (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.
The purpose of this study is to determine and compare the persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF.
Detailed description
Actual number of patients enrolled for UK : 15242 patients
Actual number of patients enrolled for Germany : 22880 patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient treated with Apixaban | – | – |
| Patient treated with Rivaroxaban | – | – |
| Patient treated with Dabigatran | – | – |
| Patient treated with vitamin K antagonists | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (4 listed)
- Have an apixaban, rivaroxaban, dabigatran or VKA prescription during the study period
- Are ≥18 years old at index date
- Have ≥12 months of computerised medical data prior to index date
- Have a record of AF on or ever prior to index date (index OAC prescription)
Key exclusion criteria (2 listed)
- Have a record for a valvular condition (ie, rheumatic valvular disease and prosthetic valves) on or ever prior to index date
- Have a history (ever prior to index date) of the Oral anticoagulant (OACs) which are prescribed during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF)
Time frame: 23 months for the UK and Germany, 25 months for France
We defined non-persistence in the databases as the absence of index prescription for twice the median prescription duration; and calculated cumulative incidence (95% CIs) of persistence at the end of follow-up and at different time points after treatment initiation (3, 6, and 12 months)
4 secondary outcomes
Demographic characteristics (Age, Gender, Smoking status, region of practice, data source) of patients with newly prescribed oral anticoagulants
Time frame: 23 months for the UK and Germany, 25 months for France
Clinical characteristics (History of bleeding, myocardial infarction, stroke, Thromboembolism, congestive heart failure, vascular disease, hypertension, CHA2DS2-VASc score, HAS-BLED score, etc) of patients with newly prescribed oral anticoagulants
Time frame: 23 months for the UK and Germany, 25 months for France
Adherence to newly prescribed oral anticoagulants based on Medication possession ratio (MPR)
Time frame: 23 months for the UK and Germany
Compare persistence rates across oral anticoagulant therapies
Time frame: 23 months for the UK and Germany, 25 months for France
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 20 Dec 2016.
- Derived from this study: PubMed 29398546Collings SL, Vannier-Moreau V, Johnson ME, Stynes G, Lefevre C, Maguire A, Asmar J, Bizouard G, Duhot D, Mouquet F, Fauchier L. Initiation and continuation of oral anticoagulant prescriptions for stroke prevention in non-valvular atrial fibrillation: A cohort study in primary care in France. Arch Cardiovasc Dis. 2018 May;111(5):370-379. doi: 10.1016/j.acvd.2017.10.003. Epub 2018 Feb 3.
- Derived from this study: PubMed 27678530Johnson ME, Lefevre C, Collings SL, Evans D, Kloss S, Ridha E, Maguire A. Early real-world evidence of persistence on oral anticoagulants for stroke prevention in non-valvular atrial fibrillation: a cohort study in UK primary care. BMJ Open. 2016 Sep 26;6(9):e011471. doi: 10.1136/bmjopen-2016-011471.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation, run by Bristol-Myers Squibb.
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 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Persistence rate of newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation(NVAF) (time frame: 23 months for the UK and Germany, 25 months for France). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488421, which also lists 2 linked publications.
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 20 Dec 2016.