Use of Direct Oral Anticoagulants in UK

NCT ID: NCT03119116

Last Updated: 2020-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2019-04-16

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.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Stroke Prevention with Rivaroxaban in NVAF Patients

All NVAF patients above 18 years for age prescribed with Rivaroxaban during the study period

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD

Stroke Prevention with Dabigatran in NVAF Patients

All NVAF patients above 18 years for age prescribed with Dabigatran during the study period

Dabigatran

Intervention Type DRUG

Oral direct thrombin inhibitors, 75mg and 150mg capsules BID

Stroke Prevention with Apixaban in NVAF Patients

All NVAF patients above 18 years for age prescribed with Apixaban during the study period

Apixaban

Intervention Type DRUG

Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD

Intervention Type DRUG

Dabigatran

Oral direct thrombin inhibitors, 75mg and 150mg capsules BID

Intervention Type DRUG

Apixaban

Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many Locations

Multiple Locations, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

Other Identifiers

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19330

Identifier Type: -

Identifier Source: org_study_id

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