Atrial FibrillationCALLIPERNCT03359876
Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction
An observational study of Atrial Fibrillation, run by Bayer at 1 site in United States.
Trial summary
The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients with renal dysfunction in routine clinical practice. 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 Warfarin sodium
- How many people
- 16,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 29 Mar 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 is all the insured individuals included in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases.To be included in the present study, adult patients have to be diagnosed with NVAF, have renal dysfunction and be newly-initiated on warfarin or rivaroxaban 15 mg for stroke prevention.
Who may be able to join
- have to be adults (≥18 years of age)
- newly-initiated on warfarin or rivaroxaban 15 mg (index event, index drug)
- have at least 365 days of continuous medical and prescription benefits prior to the index event (baseline period)
- have at least two diagnosis codes for NVAF (on outpatient or inpatient claims, at two different days) and
- have at least one diagnosis code (inpatient or outpatient) indicating renal dysfunction in the baseline period
Who cannot join
- valvular AF (at least one inpatient diagnosis in the baseline period)
- pregnancy (inpatient or outpatient diagnosis in the baseline period)
- transient cause of AF (inpatient or outpatient diagnosis in the baseline period)
- venous thromboembolism (pulmonary embolism or deep vein thrombosis) (one inpatient or outpatient diagnosis 60 days prior to or on the index date) or
- overcame a hip or knee replacement (one inpatient diagnosis or procedure code 60 days prior to or on the index date)
- have a pharmacy claim for an oral anticoagulation (OAC) dispensation (warfarin, apixaban, dabigatran, edoxaban or rivaroxaban) in the baseline period
Show all 9Show fewer
- receive both warfarin and rivaroxaban 15 mg on the index date
- have an end-stage kidney disease or be on dialysis (one inpatient or outpatient diagnosis or procedure code in the baseline period).
- For the main analysis, patients having malignant cancers (inpatient or outpatient diagnosis in the baseline period) will be excluded. A sensitivity analysis, omitting this exclusion criterion, will be performed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction Treated With Warfarin or Reduced Dose Rivaroxaban
The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients with renal dysfunction in routine clinical practice. The study has a retrospective design, and will be conducted in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin sodium
- Keywords
- Real-world study, Atrial fibrillation, Renal dysfunction, Rivaroxaban, Warfarin
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
15 mg, once daily
Warfarin sodiumDrug
Individually adjusted dose
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| Warfarin | NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention Receives: Drug: Warfarin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke
The study outcomes will be defined based on the International Classification of Diseases, 9th- and 10th-revision, Clinical Modification (ICD-9/10-CM) diagnosis codes, Current Procedural Technology, 4th-revision (CPT-4) and Healthcare Common Procedure Coding System (HCPCS) procedure codes
Measured: Retrospective analysis from August 2011 to September 2017
Intracranial hemorrhage
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Measured: Retrospective analysis from August 2011 to September 2017
Bleeding-related hospitalization
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm
Measured: Retrospective analysis from August 2011 to September 2017
Secondary outcomes (2)
Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Measured: Retrospective analysis from August 2011 to September 2017
Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Measured: Retrospecitive analysis from August 2011 to September 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Dec 2017
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 16,000 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
- NCT03359876
- Sponsor's protocol ID
- 19721
- Acronym
- CALLIPER
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2017
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vaitsiakhovich T, Coleman CI, Kleinjung F, Vardar B, Schaefer B. Worsening of kidney function in patients with atrial fibrillation and chronic kidney disease: evidence from the real-world CALLIPER study. Curr Med Res Opin. 2022 Jun;38(6):937-945. doi: 10.1080/03007995.2022.2061705. Epub 2022 Apr 22.
PubMed 35392744
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction Treated With Warfarin or Reduced Dose Rivaroxaban
- ClinicalTrials.gov ID
- NCT03359876
- Acronym / sponsor ID
- CALLIPER / 19721
- Conditions
- Atrial Fibrillation
- Keywords
- Real-world study, Atrial fibrillation, Renal dysfunction, Rivaroxaban, Warfarin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 2 Dec 2017 (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 objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients with renal dysfunction in routine clinical practice. The study has a retrospective design, and will be conducted in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention |
| Warfarin | – | Drug: Warfarin sodiumNVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention |
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 is all the insured individuals included in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases.To be included in the present study, adult patients have to be diagnosed with NVAF, have renal dysfunction and be newly-initiated on warfarin or rivaroxaban 15 mg for stroke prevention.
Key inclusion criteria (5 listed)
- have to be adults (≥18 years of age)
- newly-initiated on warfarin or rivaroxaban 15 mg (index event, index drug)
- have at least 365 days of continuous medical and prescription benefits prior to the index event (baseline period)
- have at least two diagnosis codes for NVAF (on outpatient or inpatient claims, at two different days) and
- have at least one diagnosis code (inpatient or outpatient) indicating renal dysfunction in the baseline period
Key exclusion criteria (9 listed)
- valvular AF (at least one inpatient diagnosis in the baseline period)
- pregnancy (inpatient or outpatient diagnosis in the baseline period)
- transient cause of AF (inpatient or outpatient diagnosis in the baseline period)
- venous thromboembolism (pulmonary embolism or deep vein thrombosis) (one inpatient or outpatient diagnosis 60 days prior to or on the index date) or
- overcame a hip or knee replacement (one inpatient diagnosis or procedure code 60 days prior to or on the index date)
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)15 mg, once daily | Drug | Rivaroxaban |
| Warfarin sodiumIndividually adjusted dose | Drug | Warfarin |
Primary outcome
Ischemic stroke
Time frame: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on the International Classification of Diseases, 9th- and 10th-revision, Clinical Modification (ICD-9/10-CM) diagnosis codes, Current Procedural Technology, 4th-revision (CPT-4) and Healthcare Common Procedure Coding System (HCPCS) procedure codes
Intracranial hemorrhage
Time frame: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes
Bleeding-related hospitalization
Time frame: Retrospective analysis from August 2011 to September 2017
The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm
2 secondary outcomes
Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage
Time frame: Retrospective analysis from August 2011 to September 2017
Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis
Time frame: Retrospecitive analysis from August 2011 to September 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 11 Dec 2019.
- Derived from this study: PubMed 35392744Vaitsiakhovich T, Coleman CI, Kleinjung F, Vardar B, Schaefer B. Worsening of kidney function in patients with atrial fibrillation and chronic kidney disease: evidence from the real-world CALLIPER study. Curr Med Res Opin. 2022 Jun;38(6):937-945. doi: 10.1080/03007995.2022.2061705. Epub 2022 Apr 22.
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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 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 5 inclusion and 9 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 Dec 2019. 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?
Ischemic stroke (time frame: Retrospective analysis from August 2011 to September 2017). 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?
On the ClinicalTrials.gov record for NCT03359876, which also lists 1 linked publication.
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 Dec 2019.