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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it. It is important to prescribe the correct dose of blood thinners to the right patients to ensure the treatment works however avoiding complications. In the recent years, new blood thinners have been available; they require less laboratory tests and fewer visits to a doctor compared to older therapies. This study will look at how the general practitioners in the UK prescribe blood thinners according to the instructions given by the product manufacturer. We will use primary care data that is routinely collected by the general practitioners about their patients but without any possibility to identify individual patients. The results will help us to understand the magnitude of deviation from instructions in order to ensure that the patients benefit from the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke Prevention with Rivaroxaban in NVAF Patients | All NVAF patients above 18 years for age prescribed with Rivaroxaban during the study period |
| |
| Stroke Prevention with Dabigatran in NVAF Patients | All NVAF patients above 18 years for age prescribed with Dabigatran during the study period |
| |
| Stroke Prevention with Apixaban in NVAF Patients | All NVAF patients above 18 years for age prescribed with Apixaban during the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Characteristics |
| 6 years |
| Risk factor categories |
| 6 years |
| Previous medical history |
| 12 months prior to index date |
| Previous medication history |
| 12 months prior to index date |
| Previous use of VKA |
| Ever prior to index date |
| Measure | Description | Time Frame |
|---|---|---|
| Time-trends | Characteristics of first-time use of DOACs in NVAF patients | 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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Population based on primary care databases representative of the UK population.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | 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 |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D000069604 | Dabigatran |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Dabigatran | Drug | Oral direct thrombin inhibitors, 75mg and 150mg capsules BID |
|
| Apixaban | Drug | Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID |
|
| Concurrent co-medication |
| 6 years |
| Daily dose | DOACs(new oral anticoagulants ) for stroke prevention in NVAF(Non valvular Atrial Fibrillation) patients including those with renal impairment | 6 years |
| Dose posology | DOACs for stroke prevention in NVAF patients including those with renal impairment | 6 years |
| Naive status and Non-naive status | DOACs for stroke prevention in NVAF patients including those with renal impairment | 6 years |
| Treatment Duration | DOACs for stroke prevention in NVAF patients including those with renal impairment | 6 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |