Trial Condition(s):

Stroke

Use of Direct Oral Anticoagulants in UK

Bayer Identifier:

19330

ClinicalTrials.gov Identifier:

NCT03119116

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
31336
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

many locations

many locations, United Kingdom

Status
Completed
 

Trial Design