Stroke
Conditions
Keywords
Stroke Prevention in NVAF patients
Brief summary
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.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD
DRUGDabigatran
Oral direct thrombin inhibitors, 75mg and 150mg capsules BID
DRUGApixaban
Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID
Sponsors
Janssen Scientific Affairs, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Duration | 6 years | DOACs for stroke prevention in NVAF patients including those with renal impairment |
| Demographic Characteristics | 6 years | * 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 |
| Risk factor categories | 6 years | * 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 |
| Previous medical history | 12 months prior to index date | * 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) |
| Previous medication history | 12 months prior to index date | * 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 |
| Previous use of VKA | Ever prior to index date | * Warfarin * Other Vitamin K antagonist(s) |
| Concurrent co-medication | 6 years | * Anti-coagulants * Aspirin * Clopidogrel * Other |
| Daily dose | 6 years | DOACs(new oral anticoagulants ) for stroke prevention in NVAF(Non valvular Atrial Fibrillation) patients including those with renal impairment |
| Dose posology | 6 years | DOACs for stroke prevention in NVAF patients including those with renal impairment |
| Naive status and Non-naive status | 6 years | DOACs for stroke prevention in NVAF patients including those with renal impairment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-trends | 6 years | Characteristics of first-time use of DOACs in NVAF patients |
Countries
United Kingdom
Outcome results
None listed