Atrial Fibrillation (Prevention of Stroke)RELIEFNCT02485873
Real-Life Evidence on Stroke Prevention in SPAF
An observational study of Atrial Fibrillation (Prevention of Stroke), run by Bayer at 1 site in Germany.
Trial summary
To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) 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 (Prevention of Stroke)
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939) and Vitamin K antagonists
- How many people
- 8,607 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Sep 2015
- 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
- Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window
- Diagnosis of NVAF on start date of study or anytime during 365 days before this date
- Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date)
- Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window.
Who cannot join
- Patients with valvular AF
- Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date
- Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period
- Prescriptions of < 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REal-LIfe Evidence on Stroke Prevention in Patients With Atrial Fibrillation
To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonists
- Keywords
- Non-valvular atrial fibrillation (NVAF), Pevention, 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 antagonistsDrug
As prescribed by treating physicians
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Non-valvular Atrial Fibrillation (NVAF) patients who were initiated on rivaroxaban for stroke prevention Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| Vitamin K antagonists (VKA) | NVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) for stroke prevention Receives: Drug: Vitamin K antagonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI)
Composite cardiovascular endpoint
Measured: Within 1 year after treatment start
Secondary outcomes (11)
Time to first occurrence of IS
Single cardiovascular event
Measured: Within 1 year after treatment start
Time to first occurrence of TIA
Single cardiovascular event
Measured: Within 1 year after treatment start
Time to first occurrence of IH
Single cardiovascular event
Measured: Within 1 year after treatment start
Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage
Single cardiovascular event
Measured: Within 1 year after treatment start
Time to first occurrence of MI
Single cardiovascular event
Measured: Within 1 year after treatment start
Incidence density in study population of IS
Measured: Within 1 year after treatment start
Incidence density in study population of TIA
Measured: Within 1 year after treatment start
Incidence density in study population of IH
Measured: Within 1 year after treatment start
Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage
Measured: Within 1 year after treatment start
Incidence density in study population of MI
Measured: Within 1 year after treatment start
Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI
Measured: Within 1 year after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Prevention of Stroke)Studies 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
- 8,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485873
- Sponsor's protocol ID
- 18073
- Other IDs
- DBOX 2014/00799
- Acronym
- RELIEF
- Status last verified
- Nov 2015
- First submitted
- 28 May 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal-LIfe Evidence on Stroke Prevention in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02485873
- Acronym / sponsor ID
- RELIEF / 18073
- Keywords
- Non-valvular atrial fibrillation (NVAF), Pevention, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,607 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Jun 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.
To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) 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)Non-valvular Atrial Fibrillation (NVAF) patients who were initiated on rivaroxaban for stroke prevention |
| Vitamin K antagonists (VKA) | – | Drug: Vitamin K antagonistsNVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) 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 (4 listed)
- Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window
- Diagnosis of NVAF on start date of study or anytime during 365 days before this date
- Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date)
- Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window.
Key exclusion criteria (4 listed)
- Patients with valvular AF
- Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date
- Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period
- Prescriptions of < 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort
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 |
| Vitamin K antagonistsAs prescribed by treating physicians | Drug | Vitamin K antagonists (VKA) |
Primary outcome
Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI)
Time frame: Within 1 year after treatment start
Composite cardiovascular endpoint
11 secondary outcomes
Time to first occurrence of IS
Time frame: Within 1 year after treatment start
Time to first occurrence of TIA
Time frame: Within 1 year after treatment start
Time to first occurrence of IH
Time frame: Within 1 year after treatment start
Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage
Time frame: Within 1 year after treatment start
Time to first occurrence of MI
Time frame: Within 1 year after treatment start
Incidence density in study population of IS
Time frame: Within 1 year after treatment start
Incidence density in study population of TIA
Time frame: Within 1 year after treatment start
Incidence density in study population of IH
Time frame: Within 1 year after treatment start
Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage
Time frame: Within 1 year after treatment start
Incidence density in study population of MI
Time frame: Within 1 year after treatment start
Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI
Time frame: Within 1 year after treatment start
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 11 Nov 2015.
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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.
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 (Prevention of Stroke), run by Bayer at 1 site in Germany.
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 4 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 11 Nov 2015. 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 Germany. 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 to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI) (time frame: Within 1 year after treatment start). 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 11 Nov 2015.