Atrial FibrillationNCT02960880
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Germany.
Trial summary
The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany. 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, BAY597939) and Phenprocoumon (branded and generics)
- How many people
- 99,999 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2016to 31 Dec 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 newly initiated with Rivaroxaban or Phenprocoumon with an NVAF diagnosis from January 1, 2012 through December 31, 2015. Patients will be identified from the HRI research database, a complete longitudinal dataset of patients under statutory health insurance in Germany.
Who may be able to join
- First dispense date of Rivaroxaban (15mg or 20mg - PZN based) or Phenprocoumon (PZN based) between January 1, 2012 and December 31, 2015
- At least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of NVAF (ICD-10 GM I48.0/I48.1/I48.2/I48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter
- Patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period)
- ≥ 18 years of age
Who cannot join
- Patients with valvular AF [4 quarters prior to the index date]
- Pregnancy [4 quarters prior to index date]
- Malignant cancers [4 quarters prior to the index date or "condition after"]
- Transient cause of AF [4 quarters prior to index date]
- Patients with VTE (pulmonary embolism or DVT) [60 days before index]
- Patients with major surgery defined as hip or knee replacement [60 days before index]
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- Prescriptions of OACs (Rivaroxaban, VKA, Dabigatran, Apixaban) before index date [4 quarters prior to index date]
- Patients receiving more than one anticoagulant substance (Apixaban, Dabigatran, Rivaroxaban or Phenprocoumon) or more than one dosage of a substance on the index date
- For sensitivity analysis : Patient with any of the events defined in the combined endpoints [4 quarters prior to index date or "condition after"
- Patients with dialysis [4 quarters prior to index date]
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY597939), Phenprocoumon (branded and generics)
- Keywords
- Rivaroxaban, Phenprocoumon, retrospective cohort study, Non-Valvular Atrial fibrillation, NVAF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY597939)Drug
15mg, 20mg
Phenprocoumon (branded and generics)Drug
Individually adjusted dose
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | NVAF patients who were newly initiated on Rivaroxaban for stroke prevention Receives: Drug: Rivaroxaban (Xarelto, BAY597939) | |
| Phenprocoumon | NVAF patients who were newly initiated on Phenprocoumon for stroke prevention Receives: Drug: Phenprocoumon (branded and generics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis
Measured: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
Measured: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Secondary outcomes (4)
Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
Measured: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
Measured: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
Measured: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
Measured: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start15 Oct 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 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
- 99,999 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
- NCT02960880
- Sponsor's protocol ID
- 18735
- Status last verified
- Dec 2017
- First submitted
- 12 Oct 2016
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists
- ClinicalTrials.gov ID
- NCT02960880
- Acronym / sponsor ID
- 18735
- Conditions
- Atrial Fibrillation
- Keywords
- Rivaroxaban, Phenprocoumon, retrospective cohort study, Non-Valvular Atrial fibrillation, NVAF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99,999 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 10 Nov 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.
The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY597939)NVAF patients who were newly initiated on Rivaroxaban for stroke prevention |
| Phenprocoumon | – | Drug: Phenprocoumon (branded and generics)NVAF patients who were newly initiated on Phenprocoumon 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 newly initiated with Rivaroxaban or Phenprocoumon with an NVAF diagnosis from January 1, 2012 through December 31, 2015. Patients will be identified from the HRI research database, a complete longitudinal dataset of patients under statutory health insurance in Germany.
Key inclusion criteria (4 listed)
- First dispense date of Rivaroxaban (15mg or 20mg - PZN based) or Phenprocoumon (PZN based) between January 1, 2012 and December 31, 2015
- At least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of NVAF (ICD-10 GM I48.0/I48.1/I48.2/I48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter
- Patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period)
- ≥ 18 years of age
Key exclusion criteria (10 listed)
- Patients with valvular AF [4 quarters prior to the index date]
- Pregnancy [4 quarters prior to index date]
- Malignant cancers [4 quarters prior to the index date or "condition after"]
- Transient cause of AF [4 quarters prior to index date]
- Patients with VTE (pulmonary embolism or DVT) [60 days before index]
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, BAY597939)15mg, 20mg | Drug | Rivaroxaban |
| Phenprocoumon (branded and generics)Individually adjusted dose | Drug | Phenprocoumon |
Primary outcome
Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis
Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
4 secondary outcomes
Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 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 26 Dec 2017.
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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, 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 10 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 26 Dec 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 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?
Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis (time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)). 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 26 Dec 2017.