Clinical trial NCT03119116: Use of Direct Oral Anticoagulants in UK
Official title: Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke Prevention in NVAF patients
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2017-04-18
Enrollment: 31336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population based on primary care databases representative of the UK population.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Demographic Characteristics
timeFrame: 6 years
measure: Risk factor categories
timeFrame: 6 years
measure: Previous medical history
timeFrame: 12 months prior to index date
measure: Previous medication history
timeFrame: 12 months prior to index date
measure: Previous use of VKA
timeFrame: Ever prior to index date
measure: Concurrent co-medication
timeFrame: 6 years
measure: Daily dose
timeFrame: 6 years
measure: Dose posology
timeFrame: 6 years
measure: Naive status and Non-naive status
timeFrame: 6 years
measure: Treatment Duration
timeFrame: 6 years
Secondary outcomes:
measure: Time-trends
timeFrame: 6 years
Other outcomes:
Locations:
city: Multiple Locations
country: United Kingdom
facility: Many Locations
Study officials:
References: