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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS28234 | Other Identifier | ENCePP |
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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as treatment for Stroke Prevention in Atrial Fibrillation (SPAF). Purpose of the study is to learn more about the safety and how well the drugs rivaroxaban, apixaban and warfarin work in patients appropriately and inappropriately receiving standard and reduced doses of each drug for reducing the risk of stroke in atrial fibrillation. Real world data from routine general practice stored in the primary care database in the UK, The Health Improvement Network (THIN), will be used for investigation.
Primary objectives are to assess the safety and effectiveness of rivaroxaban, apixaban and warfarin based on the risk of intracranial hemorrhage and hemorrhagic strokes (safety) and ischemic stroke, systemic embolism and myocardial infarction (effectiveness). Secondary objectives comprise the assessment of the mentioned risks in subpopulations of patients with renal impairment or diabetes, mortality rates, and drug utilisation as well as patient characteristics before and after the first intracranial hemorrhage or ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVAF-patients_1 | Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin. |
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| NVAF-patients_2 | Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin. |
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| NVAF-patients_3 | Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Rivaroxaban at a dose of 15 or 20 mg once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Risk of intracranial hemorrhage | Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage. | Retrospective analysis of data from 2012 to 2017 |
| Risk of ischemic events | Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction. | Retrospective analysis of data from 2012 to 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of intracranial hemorrhage in NVAF-patients with renal impairment | Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage. | Retrospective analysis of data from 2012 to 2017 |
| Risk of ischemic events in NVAF-patients with renal impairment |
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Inclusion Criteria:
Exclusion Criteria:
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UK population sample representative for age, sex and geographic distribution
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many facilities | Many Sites | United Kingdom |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| Apixaban (Eliquis) | Drug | Apixaban at a dose of 2.5 or 5 mg twice daily |
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| Warfarin | Drug | Warfarin dose as prescribed by medical practitioner |
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Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction. |
| Retrospective analysis of data from 2012 to 2017 |
| Risk of intracranial hemorrhage in NVAF-patients with diabetes | Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage. | Retrospective analysis of data from 2012 to 2017 |
| Risk of ischemic events in NVAF-patients with diabetes | Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction. | Retrospective analysis of data from 2012 to 2017 |
| All-cause mortality | Rate of deaths from all causes. | Retrospective analysis of data from 2012 to 2017 |
| Drug utilisation | Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation. | Retrospective analysis of data from 2012 to 2017 |
| Drug utilisation after first intracranial hemorrhage or ischemic stroke | Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation. | Retrospective analysis of data from 2012 to 2017 |
| Patient characteristics | Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends. | Retrospective analysis of data from 2012 to 2017 |
| Patient characteristics after first intracranial hemorrhage or ischemic stroke | Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends. | Retrospective analysis of data from 2012 to 2017 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| D014859 | Warfarin |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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