Atrial FibrillationNCT03462446
Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Spain.
Trial summary
The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same… 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 Vitamin K antagonists (VKAs)
- How many people
- 249 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2015to 1 May 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
- Adult, Older adult
Study population: Selected population will include records registered in electronic databases of patients diagnosed with nonvalvular AF, receiving treatment with VKAs or rivaroxaban for one year.
Who may be able to join
- Older than 18 years
- Diagnosis of non-valvular AF (ICD code 427.31)
- Pharmacological treatment with VKAs or rivaroxaban following diagnosis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists
The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonists (VKAs)
- Keywords
- Atrial fibrillation, VKA, 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
Vitamin K antagonists (VKAs)Drug
As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group with Rivaroxaban | Patients treated with Rivaroxaban Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| Control group with VKAs | Patients treated with VKAs. This control group will be subsequently divided based on the TTR value in the last 6 months (below 65% and above 65%). Receives: Drug: Vitamin K antagonists (VKAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in therapeutic range (TTR) values in the last 6 months
Measured: 6 months
Presence of stroke
Presence of stroke prior and subsequent to treatment
Measured: 12 months
Active substance received
Rivaroxaban or VKAs (Acenocoumarol and Warfarin)
Measured: 12 months
Secondary outcomes (5)
Date of stroke
Measured: 12 months
Type of stroke
Type of stroke acccording to patients group: unknown, haemorrhagic or ischaemic.
Measured: 12 months
Duration of treatment (in days)
Measured: 12 months
Dose of the prescribed treatment
Measured: 12 months
Frequency of the prescribed treatment (in hours)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Jun 2015
- Primary completion1 May 2016
- Study completion1 May 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
- 249 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
- NCT03462446
- Sponsor's protocol ID
- 18231
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists
- ClinicalTrials.gov ID
- NCT03462446
- Acronym / sponsor ID
- 18231
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, VKA, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 12 Mar 2018 (actual)
- 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 main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group with Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Patients treated with Rivaroxaban |
| Control group with VKAs | – | Drug: Vitamin K antagonists (VKAs)Patients treated with VKAs. This control group will be subsequently divided based on the TTR value in the last 6 months (below 65% and above 65%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Selected population will include records registered in electronic databases of patients diagnosed with nonvalvular AF, receiving treatment with VKAs or rivaroxaban for one year.
Key inclusion criteria (3 listed)
- Older than 18 years
- Diagnosis of non-valvular AF (ICD code 427.31)
- Pharmacological treatment with VKAs or rivaroxaban following diagnosis
Key exclusion criteria (1 listed)
- -
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 | Treatment group with Rivaroxaban |
| Vitamin K antagonists (VKAs)As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin. | Drug | Control group with VKAs |
Primary outcome
Time in therapeutic range (TTR) values in the last 6 months
Time frame: 6 months
Presence of stroke
Time frame: 12 months
Presence of stroke prior and subsequent to treatment
Active substance received
Time frame: 12 months
Rivaroxaban or VKAs (Acenocoumarol and Warfarin)
5 secondary outcomes
Date of stroke
Time frame: 12 months
Type of stroke
Time frame: 12 months
Duration of treatment (in days)
Time frame: 12 months
Dose of the prescribed treatment
Time frame: 12 months
Frequency of the prescribed treatment (in hours)
Time frame: 12 months
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 12 Mar 2018.
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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 Spain.
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 1 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 12 Mar 2018. 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 Spain. 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?
Time in therapeutic range (TTR) values in the last 6 months (time frame: 6 months). The study lists 3 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 12 Mar 2018.