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This study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial fibrillation) in a UK general population using The Health Improvement Network (THIN) database.
The main aim of the study is to estimate in how many patients atrial fibrillation was diagnosed at the moment of stroke and to describe whether these patients received OAC at the time of the stroke. In addition, researchers want to learn about the relative risk of ischemic stroke when such patients did not continue OAC treatment.
The primary objectives of the study are to determine the incidence of ischemic stroke in patients registered in the British primary care THIN database and to investigate the OAC exposure, OAC treatment patterns and the relative risk of having an ischemic stroke in relation to OAC treatment for a subgroup of patients, who were diagnosed with non-valvular atrial fibrillation (NVAF) prior to ischemic stroke.
Secondary objectives are to determine the number of patients having NVAF diagnosed at the time of ischemic stroke and within 1 and 12 months after ischemic stroke; to describe cardiovascular risk factors for ischemic stroke and pharmacological treatments before and 12 months after ischemic stroke, and to estimate the case-fatality at 1 and 12 months after the occurrence of ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with ischemic stroke | Adult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018 |
| |
| NVAF patients with ischemic stroke | Adult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018 and had a diagnosis of NVAF prior to ischemic stroke (Subgroup) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral anticoagulant | Drug | Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018 | |
| Incidence of ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018 | |
| Number of NVAF patients with OAC prescription prior to ischemic stroke | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Duration of OAC treatment before OAC discontinuation for NVAF patients | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Time period from OAC discontinuation to ischemic stroke for NVAF patients | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke after OAC discontinuation | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke by time since OAC discontinuation | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke by OAC treatment duration before OAC discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with first diagnosis of NVAF at time of ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018 | |
| Number of subjects with first diagnosis of NVAF within 1 month after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jul-2018 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults from UK with electronic medical records in The Health Improvement Network (THIN) database
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many facilities | Multiple Locations | 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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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000925 | Anticoagulants |
| D014859 | Warfarin |
| D000074 | Acenocoumarol |
| D010630 | Phenindione |
| C522181 | apixaban |
| D000069604 | Dabigatran |
| C552171 | edoxaban |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
For NVAF subgroup only |
| Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke after VKA discontinuation | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke by time since VKA discontinuation | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke by VKA treatment duration before VKA discontinuation | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke after NOAC discontinuation | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke by time since NOAC discontinuation | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Relative risk of NVAF patients for ischemic stroke by NOAC treatment duration before NOAC discontinuation | For NVAF subgroup only | Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018 |
| Number of subjects with first diagnosis of NVAF within 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Prevalence of cardiovascular co-morbidities one year before ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months before ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Descriptive analysis of pharmacological treatments of patients with known NVAF diagnosis within 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months before ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Descriptive analysis of pharmacological treatments of patients without known NVAF diagnosis within 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Case-fatality of patients with known NVAF diagnosis at 1 month after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Case-fatality for patients with known NVAF diagnosis at 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Case-fatality of patients with unknown NVAF diagnosis at 1 month after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| Case-fatality of patients with unknown NVAF diagnosis at 12 months after ischemic stroke | Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D015110 |
| 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |