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Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice

NCT ID: NCT03847181

Last Updated: 2021-10-28

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

45164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-28

Study Completion Date

2020-10-31

Brief Summary

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This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as treatment for Stroke Prevention in Atrial Fibrillation (SPAF). Purpose of the study is to learn more about the safety and how well the drugs rivaroxaban, apixaban and warfarin work in patients appropriately and inappropriately receiving standard and reduced doses of each drug for reducing the risk of stroke in atrial fibrillation. Real world data from routine general practice stored in the primary care database in the UK, The Health Improvement Network (THIN), will be used for investigation.

Detailed Description

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Primary objectives are to assess the safety and effectiveness of rivaroxaban, apixaban and warfarin based on the risk of intracranial hemorrhage and hemorrhagic strokes (safety) and ischemic stroke, systemic embolism and myocardial infarction (effectiveness). Secondary objectives comprise the assessment of the mentioned risks in subpopulations of patients with renal impairment or diabetes, mortality rates, and drug utilisation as well as patient characteristics before and after the first intracranial hemorrhage or ischemic stroke.

Conditions

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Atrial Fibrillation

Keywords

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Oral anticoagulants Under-dosing Stroke prevention in atrial fibrillation Safety Effectiveness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NVAF-patients_1

Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Rivaroxaban at a dose of 15 or 20 mg once daily

NVAF-patients_2

Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.

Apixaban (Eliquis)

Intervention Type DRUG

Apixaban at a dose of 2.5 or 5 mg twice daily

NVAF-patients_3

Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.

Warfarin

Intervention Type DRUG

Warfarin dose as prescribed by medical practitioner

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban at a dose of 15 or 20 mg once daily

Intervention Type DRUG

Apixaban (Eliquis)

Apixaban at a dose of 2.5 or 5 mg twice daily

Intervention Type DRUG

Warfarin

Warfarin dose as prescribed by medical practitioner

Intervention Type DRUG

Other Intervention Names

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Non-Vitamin K Oral Anticoagulant (NOAC) Non-Vitamin K Oral Anticoagulant (NOAC) Vitamin K Antagonist

Eligibility Criteria

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Inclusion Criteria

* Patients with non-valvular atrial fibrillation
* New users of rivaroxaban, apixaban or warfarin
* At least one year enrollment with the general practice (GP)
* One year since first health contact recorded in THIN prior to the first prescription of a study drug

Exclusion Criteria

* Patients with other recent indications of oral anticoagulant initiation
* Individuals on more than one oral anticoagulant on the start date
* Users of rivaroxaban apart from 15 / 20 mg daily dose
* Users of apixaban apart from 5 / 10 mg daily dose
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen, LP

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many facilities

Many Sites, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EUPAS28234

Identifier Type: OTHER

Identifier Source: secondary_id

20343

Identifier Type: -

Identifier Source: org_study_id