Atrial FibrillationRIVA-FNCT02690155
Real-world Comparative Effectiveness of Rivaroxaban Versus VKA
An observational study of Atrial Fibrillation, run by Bayer at 1 site in United States.
Trial summary
To obtain a better understanding on the comparative effectiveness of rivaroxaban versus VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial fibrillation) in a real-life setting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939) and VKA (Vitamin K antagonist)
- How many people
- 38,831 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2016to 1 Mar 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: Patients with non-valvular atrial fibrillation (NVAF)
Who may be able to join
- NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD(International Classification of Disease)-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
- Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
- CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category)
Who cannot join
- Patients <18 years of age
- Patients with valvular AF (Atrial fibrillation)
- Pregnancy
- Malignant cancers
- Transient cause of AF
- Patients with venous thromboembolism (pulmonary embolism or deep vein thrombosis)
Show all 15Show fewer
- Patients with major surgery defined as hip or knee replacement
- Prescriptions of oral anticoagulants (OACs) (apixaban, warfarin, dabigatran, rivaroxaban) before index date
- Prescription of more than one OAC on the index date
- Patient with any of the events defined in the composite endpoint
- Fatal bleeding
- Fatal Stroke/Myocardial infarction
- Intracranial hemorrhage
- Ischemic stroke
- Myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
To obtain a better understanding on the comparative effectiveness of rivaroxaban versus VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial fibrillation) in a real-life setting
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), VKA (Vitamin K antagonist)
- Keywords
- Non-valvular atrial fibrillation (NVAF), Prevention, Stroke
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
As prescribed by treating physicians
VKA (Vitamin K antagonist)Drug
As prescribed by treating physicians
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | NVAF patients who were initiated on rivaroxaban for stroke prevention Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| VKA (Vitamin K antagonist) | NVAF patients who were initiated on VKA for stroke prevention Receives: Drug: VKA (Vitamin K antagonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hospitalization Events (composite endpoint)
Measured: Within 2 years of starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start12 Feb 2016
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- 38,831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690155
- Sponsor's protocol ID
- 18734
- Acronym
- RIVA-F
- Status last verified
- Apr 2017
- First submitted
- 19 Feb 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Comparative Effectiveness of Rivaroxaban Versus VKA
- ClinicalTrials.gov ID
- NCT02690155
- Acronym / sponsor ID
- RIVA-F / 18734
- Conditions
- Atrial Fibrillation
- Keywords
- Non-valvular atrial fibrillation (NVAF), Prevention, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38,831 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 24 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.
To obtain a better understanding on the comparative effectiveness of rivaroxaban versus VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial fibrillation) in a real-life setting
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)NVAF patients who were initiated on rivaroxaban for stroke prevention |
| VKA (Vitamin K antagonist) | – | Drug: VKA (Vitamin K antagonist)NVAF patients who were initiated on VKA for stroke prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-valvular atrial fibrillation (NVAF)
Key inclusion criteria (3 listed)
- NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD(International Classification of Disease)-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
- Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
- CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category)
Key exclusion criteria (15 listed)
- Patients <18 years of age
- Patients with valvular AF (Atrial fibrillation)
- Pregnancy
- Malignant cancers
- Transient cause of AF
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 |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)As prescribed by treating physicians | Drug | Rivaroxaban |
| VKA (Vitamin K antagonist)As prescribed by treating physicians | Drug | VKA (Vitamin K antagonist) |
Primary outcome
Incidence of Hospitalization Events (composite endpoint)
Time frame: Within 2 years of starting treatment
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 5 Apr 2017.
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Atrial Fibrillation (AF)
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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Bayer at 1 site in United States.
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 3 inclusion and 15 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Incidence of Hospitalization Events (composite endpoint) (time frame: Within 2 years of starting treatment). 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 5 Apr 2017.