Use of Direct Oral Anticoagulants in UK

Study Overview
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Brief Summary
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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.

Official Title
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Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices

Conditions
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Stroke

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Dabigatran
* Drug: Apixaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients aged >= 18 years with at least one year of enrollment with the primary care practice and one year since first health contact recorded in the database THIN(The Health Improvement Network) or CPRD(Clinical Practice Research Datalink) prior to index prescription date will be included. Patients with first prescription of DOACs (rivaroxaban, dabigatran, apixaban) during the study period. Diagnosis NVAF (any time prior index date or within the 2 weeks after the index date) Exclusion Criteria: Patients having the history of valvular replacement or mitral stenosis (prior to index date or 2 weeks after index-date) Patients who have any record of being prescribed their index drug prior to the enrolment period or who qualify as members of more than one cohort on the same day.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke Prevention with Rivaroxaban in NVAF Patients<br>All NVAF patients above 18 years for age prescribed with Rivaroxaban during the study period | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD<br>|
| Stroke Prevention with Dabigatran in NVAF Patients<br>All NVAF patients above 18 years for age prescribed with Dabigatran during the study period | Drug: Dabigatran<br>* Oral direct thrombin inhibitors, 75mg and 150mg capsules BID<br>|
| Stroke Prevention with Apixaban in NVAF Patients<br>All NVAF patients above 18 years for age prescribed with Apixaban during the study period | Drug: Apixaban<br>* Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Characteristics | Age Sex Smoking status (previous 6 months) Body mass index (previous 6 months) Blood pressure history (previous 12 months) Number of patients that are naïve vs non-naïve For non-naïve: type and duration of anticoagulant used before index date | 6 years | 
| Risk factor categories | C(Congestive heart failure) H(Hypertension)A(Age)D(Diabetes Mellitus)S2(Prior Stroke or TIA) score C(Congestive heart failure) H(Hypertension)A2(Age ≥75 years)D(Diabetes Mellitus)S2 V(Vascular disease)A(Age 65-74 years)SC(Sex category) H(Hypertension)A(Abnormal renal and liver function)S(Stroke)B(Bleeding)L(Labile INRs)E(Elderly)D(Drugs or alcohol) score INR(International Normalized Ratio) measurement | 6 years | 
| Previous medical history | Acute MI(Myocardial Infarction) Stroke or TIA(Transient Ischemic Attack) Systemic peripheral arterial embolism Coronary artery disease Congestive heart disease Hypertension Diabetes Renal disease (eGFR) or ACR (Albumin/Creatinine Ratio) | 12 months prior to index date | 
| Previous medication history | Anti-arrhythmics Statins Anti-platelets Beta-blockers ACE(Angiotensin-Converting-Enzyme) inhibitors Anti-diabetic agents Non-steroidal anti-inflammatory drugs (NSAIDs) Antacids Histamine receptor antagonists Proton pump inhibitors (PPIs) Disease-modifying anti-rheumatic drugs (DMARDs) Antidepressants Antipsychotic agents Oral contraceptives Hormone replacement therapy (HRT) Strong inhibitors of Cytochrome P450 or P-GP Strong inducers of CYP3A4 | 12 months prior to index date | 
| Previous use of VKA | Warfarin Other Vitamin K antagonist(s) | Ever prior to index date | 
| Concurrent co-medication | Anti-coagulants Aspirin Clopidogrel Other | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-trends | Characteristics of first-time use of DOACs in NVAF patients | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke Prevention in NVAF patients