Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy

NCT ID: NCT02921126

Last Updated: 2018-08-08

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

9914 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-30

Study Completion Date

2018-08-02

Brief Summary

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To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.

Detailed Description

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Conditions

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Anticoagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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High Dose Group

Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day

No interventions assigned to this group

Low Dose Group

Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day

No interventions assigned to this group

Other Dose Group

Invalid Doses / Off-Label

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* are at least 18 years of age at index date
* Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
* Had at least 1 claim with diagnosis of AF anytime in their records

Exclusion Criteria

* Have a record that is indicative of Valvular Atrial Fibrillation during this period
* Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)
* Have more than one OAC exposure which starts on the same date
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Ravenna, , Italy

Site Status

Countries

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Italy

Related Links

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Other Identifiers

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CV185-494

Identifier Type: -

Identifier Source: org_study_id

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