Atrial FibrillationReLoaDeDNCT03563937
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Germany.
Trial summary
Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. 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?
- Phenprocoumon, Apixaban and Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 64,920 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2018to 10 Dec 2019
- 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: The source population of this study will include all insured members of approximately 64 German statutory health insurances (SHIs) contributing data to the InGef database.
Who may be able to join
- First NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription (index drug) in the enrollment period between 1st January 2013 to 30th June 2017 (index date).
- Age of at least 18 years at index date.
- Continuous enrollment in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of NVAF in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
Who cannot join
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of valvular atrial fibrillation, indicating pregnancy, transient cause of atrial fibrillation or venous thromboembolism (VTE).
- A claim for hip or knee replacement surgery in the 60 days prior to or on the index date.
- A prescription of more than one oral anticoagulant (rivaroxaban, apixaban, edoxaban or phenprocoumon) on the index date.
- A prescription of warfarin or dabigatran in the baseline period or on the index date.
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period.
- Patients receiving an initial dose of rivaroxaban 10 mg/ 2.5 mg or edoxaban 15 mg (these dosages are not indicated for the treatment of NVAF).
Trial locations and contacts
1 site in 1 country.
About this study
Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. Nevertheless, it is known that clinicians often hesitate to prescribe NOACs to patients with even moderate renal impairment. Therefore, it is important to investigate effectiveness and safety of rivaroxaban and other NOACs compared to vitamin-K antagonists in NVAF patients with renal dysfunction in real life setting.
The primary objectives of this study are to describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon.
- Conditions
- Atrial Fibrillation
- Being tested
- Phenprocoumon, Apixaban, Rivaroxaban (Xarelto, BAY59-7939), Edoxaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenprocoumonDrug
Follow the physician's prescription.
ApixabanDrug
2.5 mg or 5 mg, twice daily
Rivaroxaban (Xarelto, BAY59-7939)Drug
15 mg or 20 mg, once daily
EdoxabanDrug
30 mg or 60 mg, once daily
| Study group | Role | What they receive |
|---|---|---|
| Phenprocoumon | Patients with NVAF who initiated the treatment of Phenprocoumon. Receives: Drug: Phenprocoumon | |
| Apixaban | Patients with NVAF who initiated the treatment of Apixaban. Receives: Drug: Apixaban | |
| Rivaroxaban (Xarelto, BAY59-7939) | Patients with NVAF who initiated the treatment of Rivaroxaban. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| Edoxaban | Patients with NVAF who initiated the treatment of Edoxaban. Receives: Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Ischemic stroke (IS) / Systemic embolism(SE) (as combined endpoint and alone), recurrent IS/SE (as combined endpoint) and severe IS in patients with NVAF and renal impairment determined by inpatient claims based diagnoses
Severe IS will be defined according to an approach proposed by Schubert et al. as hospitalization with a primary hospital discharge diagnosis of IS in combination with an OPS (Operationen und Prozedurenschlüssel) code indicating one of the following: intubation, mechanical ventilation or percutaneous endoscopic gastronomy
Measured: Retrospective analysis from January 2012 - December 2017
Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses
Measured: Retrospective analysis from January 2012 - December 2017
Healthcare resource consumption in patients with non-valvular atrial fibrillation (NVAF) and renal impairment determined by inpatient claims based diagnoses
Measured: Retrospective analysis from January 2012 - December 2017
Overall costs in patients with renal impairment determined by inpatient claims based diagnoses
Measured: Retrospective analysis from January 2012 - December 2017
Sector specific costs in patients with renal impairment determined by inpatient claims based diagnoses
Measured: Retrospective analysis from January 2012 - December 2017
Secondary outcomes (6)
Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses
Fatal bleeding will be defined as hospitalization with a primary hospital discharge diagnoses for bleeding with documented death as reason for hospital discharge or within 30 days after hospital discharge.
Measured: Retrospective analysis from January 2012 - December 2017
Risk of recurrent hospitalizations (in general and for IS/SE)
Measured: Retrospective analysis from January 2012 - December 2017
Risk of Kidney failure determined by inpatient claims based diagnoses
Measured: Retrospective analysis from January 2012 - December 2017
Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses
Measured: Retrospective analysis from January 2012 - December 2017
Risk of treatment discontinuation in patients with NVAF (overall population as well as patients with renal impairment) determined by pharmacy claims
Measured: Retrospective analysis from January 2012 - December 2017
Risk of IS, SE, Severe IS and recurrent IS/SE in patient with NVAF determined determined by inpatient claims based diagnoses
Measured: Retrospective analysis from January 2012 - December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start15 Jun 2018
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
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
- 64,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563937
- Sponsor's protocol ID
- 20031
- Acronym
- ReLoaDeD
- Status last verified
- Nov 2020
- First submitted
- 11 Jun 2018
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. 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 Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon
- ClinicalTrials.gov ID
- NCT03563937
- Acronym / sponsor ID
- ReLoaDeD / 20031
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64,920 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 20 Jun 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.
Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. Nevertheless, it is known that clinicians often hesitate to prescribe NOACs to patients with even moderate renal impairment. Therefore, it is important to investigate effectiveness and safety of rivaroxaban and other NOACs compared to vitamin-K antagonists in NVAF patients with renal dysfunction in real life setting.
The primary objectives of this study are to describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phenprocoumon | – | Drug: PhenprocoumonPatients with NVAF who initiated the treatment of Phenprocoumon. |
| Apixaban | – | Drug: ApixabanPatients with NVAF who initiated the treatment of Apixaban. |
| Rivaroxaban (Xarelto, BAY59-7939) | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Patients with NVAF who initiated the treatment of Rivaroxaban. |
| Edoxaban | – | Drug: EdoxabanPatients with NVAF who initiated the treatment of Edoxaban. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population of this study will include all insured members of approximately 64 German statutory health insurances (SHIs) contributing data to the InGef database.
Key inclusion criteria (4 listed)
- First NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription (index drug) in the enrollment period between 1st January 2013 to 30th June 2017 (index date).
- Age of at least 18 years at index date.
- Continuous enrollment in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of NVAF in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
Key exclusion criteria (6 listed)
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of valvular atrial fibrillation, indicating pregnancy, transient cause of atrial fibrillation or venous thromboembolism (VTE).
- A claim for hip or knee replacement surgery in the 60 days prior to or on the index date.
- A prescription of more than one oral anticoagulant (rivaroxaban, apixaban, edoxaban or phenprocoumon) on the index date.
- A prescription of warfarin or dabigatran in the baseline period or on the index date.
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period.
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 |
|---|---|---|
| PhenprocoumonFollow the physician's prescription. | Drug | Phenprocoumon |
| Apixaban2.5 mg or 5 mg, twice daily | Drug | Apixaban |
| Rivaroxaban (Xarelto, BAY59-7939)15 mg or 20 mg, once daily | Drug | Rivaroxaban (Xarelto, BAY59-7939) |
| Edoxaban30 mg or 60 mg, once daily | Drug | Edoxaban |
Primary outcome
Risk of Ischemic stroke (IS) / Systemic embolism(SE) (as combined endpoint and alone), recurrent IS/SE (as combined endpoint) and severe IS in patients with NVAF and renal impairment determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Severe IS will be defined according to an approach proposed by Schubert et al. as hospitalization with a primary hospital discharge diagnosis of IS in combination with an OPS (Operationen und Prozedurenschlüssel) code indicating one of the following: intubation, mechanical ventilation or percutaneous endoscopic gastronomy
Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Healthcare resource consumption in patients with non-valvular atrial fibrillation (NVAF) and renal impairment determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Overall costs in patients with renal impairment determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Sector specific costs in patients with renal impairment determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
6 secondary outcomes
Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of recurrent hospitalizations (in general and for IS/SE)
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of Kidney failure determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of treatment discontinuation in patients with NVAF (overall population as well as patients with renal impairment) determined by pharmacy claims
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of IS, SE, Severe IS and recurrent IS/SE in patient with NVAF determined determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
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 27 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 6 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 27 Nov 2020. 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 (IS) / Systemic embolism(SE) (as combined endpoint and alone), recurrent IS/SE (as combined endpoint) and severe IS in patients with NVAF and renal impairment determined by inpatient claims based diagnoses (time frame: Retrospective analysis from January 2012 - December 2017). The study lists 5 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 27 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.